Possible Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer I2 Models disagreeI3 Models disagreeI4 UnknownI5 UnknownE1 UnknownE2 UnknownE3 UnknownAGE-MIN MetI1 Met Phase not given, GFPC Investigation. Nearest site: Pringy, France, 29 km away. 7 questions to clarify.
Ask before referring
- I2 Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.Writer said not met, checker said unknown. Patient has EGFR L858R (exon 21), not exon 20 insertion, and did not receive amivantamab.
- I3 Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.Writer said not met, checker said unknown. Patient did not receive amivantamab-platinum chemotherapy; received standard chemo after osimertinib.
- I4 Patient covered by the French National Health Insurance system or by an approved third-party payerNo facts provided regarding insurance or payer status.
- I5 Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)No facts provided regarding patient consent or objection to data collection.
- E1 Patient placed under legal guardianship or subject to a protective legal measureAnswer cited no patient fact.
- E2 Patient who explicitly refuses the collection or use of their personal data for research purposesAnswer cited no patient fact.
- E3 Patient not enrolled, managed, or followed at the investigating site by a qualified site investigatorNo facts provided about the patient's current managing site or investigator.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Patient over 18 years old
Met, judged by both models, using F1
Patient is 73 years old, which is over 18.
I2 Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.
Models disagree, judged by models disagree, using F3 F4
Writer said not met, checker said unknown. Patient has EGFR L858R (exon 21), not exon 20 insertion, and did not receive amivantamab.
I3 Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.
Models disagree, judged by models disagree, using F3 F4 F5
Writer said not met, checker said unknown. Patient did not receive amivantamab-platinum chemotherapy; received standard chemo after osimertinib.
I4 Patient covered by the French National Health Insurance system or by an approved third-party payer
Unknown, judged by first model only
No facts provided regarding insurance or payer status.
I5 Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)
Unknown, judged by first model only
No facts provided regarding patient consent or objection to data collection.
E1 Patient placed under legal guardianship or subject to a protective legal measure
Unknown, judged by first model only
Answer cited no patient fact.
E2 Patient who explicitly refuses the collection or use of their personal data for research purposes
Unknown, judged by first model only
Answer cited no patient fact.
E3 Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator
Unknown, judged by first model only
No facts provided about the patient's current managing site or investigator.
Not eligible Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) I3 Not metE2 Models disagreeE3 Models disagreeE4 At screeningAGE-MIN MetI1 MetI2 MetI4 MetE1 Does not apply Phase 2, Phase 3, Bristol-Myers Squibb. Nearest site: Bron, France, 108 km away. 2 questions to clarify.
Ask before referring
- E2 Leptomeningeal metastases or spinal cord compression.Writer said does not apply, checker said unknown. Brain metastasis is parenchymal, not leptomeningeal or spinal cord compression.
- E3 Poorly controlled systemic medical conditions.Writer said does not apply, checker said unknown. ECOG 2 and resolved pneumonitis are not poorly controlled conditions.
What rules the patient out
- I3 Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.Most recent line was chemotherapy, not a 3rd-generation EGFR-TKI.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Non-squamous NSCLC, not amenable to treatment in curative intent.
Met, judged by both models, using F2
Stage IV non-squamous NSCLC is not amenable to curative intent.
I2 Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
Met, judged by both models, using F3
EGFR L858R mutation is documented.
I3 Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
Not met, judged by both models, using F4 F5
Most recent line was chemotherapy, not a 3rd-generation EGFR-TKI.
I4 Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).
Met, judged by both models, using F9
Creatinine clearance 42 mL/min allows carboplatin use.
E1 Inadequate organ function and/or bone marrow reserve.
Does not apply, judged by both models, using F9
Other labs normal; CrCl 42 is acceptable for carboplatin.
E2 Leptomeningeal metastases or spinal cord compression.
Models disagree, judged by models disagree, using F10
Writer said does not apply, checker said unknown. Brain metastasis is parenchymal, not leptomeningeal or spinal cord compression.
E3 Poorly controlled systemic medical conditions.
Models disagree, judged by models disagree, using F7 F11
Writer said does not apply, checker said unknown. ECOG 2 and resolved pneumonitis are not poorly controlled conditions.
E4 Other protocol-defined inclusion/exclusion criteria apply.
At screening, judged by code
Confirmed at screening (consent, pregnancy or protocol).
Not eligible Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) I4 Not metE1 Models disagreeE2 UnknownE3 UnknownE4 At screeningAGE-MIN MetI1 MetI2 MetI3 Met Phase 3, Bristol-Myers Squibb. Nearest site: Bron, France, 108 km away. 3 questions to clarify.
Ask before referring
- E1 Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compressionWriter said does not apply, checker said applies. Brain metastasis is asymptomatic and untreated, not unstable or symptomatic.
- E2 Participants must not have history of ILD/pneumonitis requiring treatment with steroids (>= Grade 2), or current or suspected ILD/pneumonitisHistory of pneumonitis exists, but steroid use requirement is not specified.
- E3 Participants must not have clinically significant cardiac diseaseNo facts provided regarding cardiac disease status.
What rules the patient out
- I4 Participants must have ECOG Performance Status 0-1ECOG status is 2, which exceeds the required 0-1 range.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment
Met, judged by both models, using F2
Patient has Stage IV non-squamous NSCLC requiring systemic treatment.
I2 Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)
Met, judged by both models, using F3
Documented EGFR L858R mutation is a sensitizing mutation.
I3 Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator
Met, judged by both models, using F8
Measurable disease confirmed by RECIST 1.1.
I4 Participants must have ECOG Performance Status 0-1
Not met, judged by both models, using F7
ECOG status is 2, which exceeds the required 0-1 range.
E1 Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression
Models disagree, judged by models disagree, using F10
Writer said does not apply, checker said applies. Brain metastasis is asymptomatic and untreated, not unstable or symptomatic.
E2 Participants must not have history of ILD/pneumonitis requiring treatment with steroids (>= Grade 2), or current or suspected ILD/pneumonitis
Unknown, judged by first model only, using F11
History of pneumonitis exists, but steroid use requirement is not specified.
E3 Participants must not have clinically significant cardiac disease
Unknown, judged by first model only
No facts provided regarding cardiac disease status.
E4 Other protocol-defined inclusion/exclusion criteria apply.
At screening, judged by code
Confirmed at screening (consent, pregnancy or protocol).
Not eligible Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations I4 Not metI7 Not metI3 Models disagreeI1 UnknownI5 UnknownAGE-MIN MetI2 MetI6 Met Phase 3, ArriVent BioPharma, Inc.. Nearest site: Bron, France, 108 km away. 3 questions to clarify.
Ask before referring
- I1 Key Eligibility Criteria:The specific text for 'Key Eligibility Criteria' is not provided in the input.
- I3 Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.Writer said met, checker said not met. EGFR mutation was detected on tissue sequencing at diagnosis.
- I5 Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.Invalid answer 'does_not_apply'.
What rules the patient out
- I4 No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).Patient received prior osimertinib (EGFR TKI) and chemotherapy for metastatic disease.
- I7 List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K E709_T710delinsD, E709_T710delinsA, E709_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740_K745dup, I740_K745dupIPVAIK, I744_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768_V769delinsIL, S768_V769delinsIM, S768_V769delinsPL, V769L, V769M, N771G, H773_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750_I759delinsPN, T751_I759delinsNEGFR L858R is not listed in the eligible PACC mutation list.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Key Eligibility Criteria:
Unknown, judged by first model only
The specific text for 'Key Eligibility Criteria' is not provided in the input.
I2 Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
Met, judged by both models, using F2
Patient has stage IV non-small cell lung cancer, which is metastatic.
I3 Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.
Models disagree, judged by models disagree, using F3
Writer said met, checker said not met. EGFR mutation was detected on tissue sequencing at diagnosis.
I4 No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
Not met, judged by both models, using F4 F5
Patient received prior osimertinib (EGFR TKI) and chemotherapy for metastatic disease.
I5 Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.
Unknown, judged by first model only
Invalid answer 'does_not_apply'.
I6 Patients with asymptomatic CNS metastases are eligible.
Met, judged by both models, using F10
Patient has an asymptomatic brain metastasis, which is explicitly eligible.
I7 List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K E709_T710delinsD, E709_T710delinsA, E709_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740_K745dup, I740_K745dupIPVAIK, I744_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768_V769delinsIL, S768_V769delinsIM, S768_V769delinsPL, V769L, V769M, N771G, H773_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750_I759delinsPN, T751_I759delinsN
Not met, judged by both models, using F3
EGFR L858R is not listed in the eligible PACC mutation list.
Not eligible Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion I1 Not metI3 Not metE1 Models disagreeI5 UnknownI6 UnknownE2 UnknownI4 At screeningAGE-MIN MetI2 Met n/a, Groupe Francais De Pneumo-Cancerologie. Nearest site: Villeurbanne, France, 109 km away. 4 questions to clarify.
Ask before referring
- I5 Confirmed progression on amivantamab according to RECIST 1.1;No facts indicate current or prior amivantamab treatment.
- I6 Patient enrolled in the french National Health Insurance program or with a third- party payer.No facts regarding insurance or payer status.
- E1 Patients receiving amivantamab in combination with another therapy;Writer said does not apply, checker said unknown. Patient is not currently receiving amivantamab.
- E2 Patients who do not consent to liquid biopsy at progression.No facts regarding patient consent for liquid biopsy.
What rules the patient out
- I1 All patients with advanced NSCLC with EGFR ins20 receiving amivantamab as monotherapy in France under ATU or EAP;Patient has EGFR L858R mutation, not EGFR ins20.
- I3 Histologically confirmed advanced NSCLC (metastatic or locally advanced unresectable and not suitable for definitive radiotherapy) with EGFR ins20;Patient has EGFR L858R mutation, not EGFR ins20.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 All patients with advanced NSCLC with EGFR ins20 receiving amivantamab as monotherapy in France under ATU or EAP;
Not met, judged by both models, using F3
Patient has EGFR L858R mutation, not EGFR ins20.
I2 Age >= 18 years;
Met, judged by both models, using F1
Patient is 73 years old, which is >= 18.
I3 Histologically confirmed advanced NSCLC (metastatic or locally advanced unresectable and not suitable for definitive radiotherapy) with EGFR ins20;
Not met, judged by both models, using F2 F3
Patient has EGFR L858R mutation, not EGFR ins20.
I4 Patients included will be required to sign an informed consent form to collect blood samples (liquid biopsy) and tissue biopsy when available at progression on amivantamab;
At screening, judged by code
Confirmed at screening (consent, pregnancy or protocol).
I5 Confirmed progression on amivantamab according to RECIST 1.1;
Unknown, judged by first model only
No facts indicate current or prior amivantamab treatment.
I6 Patient enrolled in the french National Health Insurance program or with a third- party payer.
Unknown, judged by first model only
No facts regarding insurance or payer status.
E1 Patients receiving amivantamab in combination with another therapy;
Models disagree, judged by models disagree, using F4 F5
Writer said does not apply, checker said unknown. Patient is not currently receiving amivantamab.
E2 Patients who do not consent to liquid biopsy at progression.
Unknown, judged by first model only
No facts regarding patient consent for liquid biopsy.
Not eligible A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) I3 Not metI4 Not metE2 Applies, excludesE1 Models disagreeI5 UnknownE3 UnknownE4 UnknownE5 UnknownE6 UnknownAGE-MIN MetI1 MetI2 Met Phase 3, Bayer. Nearest site: Fribourg, Switzerland, 102 km away. 6 questions to clarify.
Ask before referring
- I5 Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.Facts do not specify if patient meets specific SmPC eligibility for this regimen.
- E1 Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:; a. in situ cancers of cervix, breast, or skin,; b. superficial bladder cancer (Ta, Tis and T1),; c. limited-stage prostate cancer,; d. basal or squamous cancers of the skin.Writer said does not apply, checker said unknown. No history of prior malignancy other than current NSCLC is listed.
- E3 Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for >4 weeks prior to planned start of study intervention.Answer cited no patient fact.
- E4 Pre-existing peripheral neuropathy that is Grade >=2 by CTCAE (v5.0).Answer cited no patient fact.
- E5 History of severe hypersensitivity reaction to treatment with a monoclonal antibody.Answer cited no patient fact.
- E6 Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.Answer cited no patient fact.
What rules the patient out
- I3 Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.Patient has EGFR mutation, not a documented HER2 TKD mutation.
- I4 No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.Patient received prior systemic therapy (osimertinib, chemo) for metastatic disease.
- E2 Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.EGFR L858R is a targetable alteration with approved therapy (osimertinib).
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Participant must be >=18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
Met, judged by both models, using F1
Patient is 73 years old, which is greater than 18.
I2 Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
Met, judged by both models, using F2
Stage IV non-squamous NSCLC (adenocarcinoma) is documented.
I3 Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
Not met, judged by both models, using F3
Patient has EGFR mutation, not a documented HER2 TKD mutation.
I4 No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
Not met, judged by both models, using F4 F5
Patient received prior systemic therapy (osimertinib, chemo) for metastatic disease.
I5 Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.
Unknown, judged by first model only
Facts do not specify if patient meets specific SmPC eligibility for this regimen.
E1 Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:; a. in situ cancers of cervix, breast, or skin,; b. superficial bladder cancer (Ta, Tis and T1),; c. limited-stage prostate cancer,; d. basal or squamous cancers of the skin.
Models disagree, judged by models disagree, using F2
Writer said does not apply, checker said unknown. No history of prior malignancy other than current NSCLC is listed.
E2 Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
Applies, excludes, judged by both models, using F3
EGFR L858R is a targetable alteration with approved therapy (osimertinib).
E3 Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for >4 weeks prior to planned start of study intervention.
Unknown, judged by first model only
Answer cited no patient fact.
E4 Pre-existing peripheral neuropathy that is Grade >=2 by CTCAE (v5.0).
Unknown, judged by first model only
Answer cited no patient fact.
E5 History of severe hypersensitivity reaction to treatment with a monoclonal antibody.
Unknown, judged by first model only
Answer cited no patient fact.
E6 Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
Unknown, judged by first model only
Answer cited no patient fact.
Not eligible A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection I2 Not metI3 Not metI4 Not metI5 Not metI6 Not metI7 Not metE2 Applies, excludesE4 Applies, excludesI8 UnknownE1 UnknownE3 UnknownE5 UnknownE6 UnknownE7 UnknownE8 UnknownE9 UnknownAGE-MIN MetI1 Met Phase 3, Taiho Oncology, Inc.. Nearest site: Bron, France, 108 km away. 8 questions to clarify.
Ask before referring
- I8 Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers.Facts do not specify if archival tissue is currently available for submission.
- E1 Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research.Answer cited no patient fact.
- E3 Has received only wedge resections (complete anatomic segmentectomy is acceptable).Answer cited no patient fact.
- E5 Unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel disease, malabsorption syndrome, or prior significant bowel resection).Answer cited no patient fact.
- E6 Has a history of any other cancer except for any of the following:; Non-melanoma skin cancer treated with curative intent; Carcinoma in situ treated with curative intent; Other curatively treated cancer, with no evidence of disease for >3 years following the end of treatment and, in the opinion of the treating physician, has no substantial risk of recurrence.; Concurrent malignancy of which natural history does not have the potential to interfere with the safety or efficacy assessment (eg, Gleason 6 prostate cancer)Answer cited no patient fact.
- E7 Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment.Answer cited no patient fact.
- E8 Active bleeding disorders.Answer cited no patient fact.
- E9 Known hypersensitivity to the ingredients in zipalertinib/placebo or any drugs similar in structure or class.Answer cited no patient fact.
What rules the patient out
- I2 Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendment (CLIA) certified (United States [US]) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt:; exon20 insertion mutations (ex20ins) or; other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) exons 18-21 of the EGFR tyrosine kinase domainPatient has L858R mutation, which is a common mutation, not uncommon or ex20ins.
- I3 Baseline imaging assessment of the brain (MRI [preferred modality] or CT scan) performed within 8 weeks prior to randomization must show no evidence of brain metastasisPatient has an untreated brain metastasis, violating the no brain metastasis requirement.
- I4 Complete surgical resection of the primary NSCLC is mandatory with negative surgical margins and systematic lymph node sampling or dissection.Patient is Stage IV, implying metastatic disease, so complete surgical resection of primary is not applicable/mandatory in this context.
- I5 Complete recovery from surgery, including post-operative wound healing, and prior adjuvant chemotherapy (if applicable) at the time of randomization. Randomization timing is defined as follows:; For participants without prior adjuvant chemotherapy: 4 weeks and 12 weeks following surgery.; For participants with prior adjuvant chemotherapy: 4 weeks and 8 weeks after the last dose of adjuvant chemotherapy.Patient is Stage IV and has received systemic therapy, not a post-surgical adjuvant setting.
- I6 Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.Patient's ECOG performance status is 2, but criteria require 0 or 1.
- I7 Pathologic (post-operative) Stage IB, IIA, IIB, or IIIA according to the AJCC 9th tumor nodes metastasis (TNM) staging system for lung cancer. In addition, participants with stage IIIB are eligible when regional lymph node involvement is N2.Patient is Stage IV, but criteria require Stage IB to IIIA (or specific IIIB).
- E2 Treatment with any of the following within the time frame specified:; Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time.; Pre-operative or post-operative or planned radiation therapy for the current lung cancer.; Any prior systemic anticancer therapy for NSCLC, including preoperative (neoadjuvant) chemotherapy, immunotherapy, or investigational therapy. (Exception: Participants who have received postoperative adjuvant platinum-based chemotherapy up to 4 cycles are permitted); Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study treatment.; Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.Patient received prior EGFR inhibitor (osimertinib) and systemic anticancer therapy.
- E4 Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis or any evidence of clinically active ILD/pneumonitis.Patient has a history of grade 2 pneumonitis, which is an exclusion criterion.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
Met, judged by both models, using F2
Patient has histologically confirmed non-small cell lung cancer with adenocarcinoma (non-squamous).
I2 Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendment (CLIA) certified (United States [US]) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt:; exon20 insertion mutations (ex20ins) or; other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) exons 18-21 of the EGFR tyrosine kinase domain
Not met, judged by both models, using F3
Patient has L858R mutation, which is a common mutation, not uncommon or ex20ins.
I3 Baseline imaging assessment of the brain (MRI [preferred modality] or CT scan) performed within 8 weeks prior to randomization must show no evidence of brain metastasis
Not met, judged by both models, using F10
Patient has an untreated brain metastasis, violating the no brain metastasis requirement.
I4 Complete surgical resection of the primary NSCLC is mandatory with negative surgical margins and systematic lymph node sampling or dissection.
Not met, judged by both models, using F2
Patient is Stage IV, implying metastatic disease, so complete surgical resection of primary is not applicable/mandatory in this context.
I5 Complete recovery from surgery, including post-operative wound healing, and prior adjuvant chemotherapy (if applicable) at the time of randomization. Randomization timing is defined as follows:; For participants without prior adjuvant chemotherapy: 4 weeks and 12 weeks following surgery.; For participants with prior adjuvant chemotherapy: 4 weeks and 8 weeks after the last dose of adjuvant chemotherapy.
Not met, judged by both models, using F2
Patient is Stage IV and has received systemic therapy, not a post-surgical adjuvant setting.
I6 Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.
Not met, judged by both models, using F7
Patient's ECOG performance status is 2, but criteria require 0 or 1.
I7 Pathologic (post-operative) Stage IB, IIA, IIB, or IIIA according to the AJCC 9th tumor nodes metastasis (TNM) staging system for lung cancer. In addition, participants with stage IIIB are eligible when regional lymph node involvement is N2.
Not met, judged by both models, using F2
Patient is Stage IV, but criteria require Stage IB to IIIA (or specific IIIB).
I8 Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers.
Unknown, judged by first model only
Facts do not specify if archival tissue is currently available for submission.
E1 Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research.
Unknown, judged by first model only
Answer cited no patient fact.
E2 Treatment with any of the following within the time frame specified:; Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time.; Pre-operative or post-operative or planned radiation therapy for the current lung cancer.; Any prior systemic anticancer therapy for NSCLC, including preoperative (neoadjuvant) chemotherapy, immunotherapy, or investigational therapy. (Exception: Participants who have received postoperative adjuvant platinum-based chemotherapy up to 4 cycles are permitted); Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study treatment.; Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.
Applies, excludes, judged by both models, using F4 F5
Patient received prior EGFR inhibitor (osimertinib) and systemic anticancer therapy.
E3 Has received only wedge resections (complete anatomic segmentectomy is acceptable).
Unknown, judged by first model only
Answer cited no patient fact.
E4 Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis or any evidence of clinically active ILD/pneumonitis.
Applies, excludes, judged by both models, using F11
Patient has a history of grade 2 pneumonitis, which is an exclusion criterion.
E5 Unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel disease, malabsorption syndrome, or prior significant bowel resection).
Unknown, judged by first model only
Answer cited no patient fact.
E6 Has a history of any other cancer except for any of the following:; Non-melanoma skin cancer treated with curative intent; Carcinoma in situ treated with curative intent; Other curatively treated cancer, with no evidence of disease for >3 years following the end of treatment and, in the opinion of the treating physician, has no substantial risk of recurrence.; Concurrent malignancy of which natural history does not have the potential to interfere with the safety or efficacy assessment (eg, Gleason 6 prostate cancer)
Unknown, judged by first model only
Answer cited no patient fact.
E7 Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment.
Unknown, judged by first model only
Answer cited no patient fact.
E8 Active bleeding disorders.
Unknown, judged by first model only
Answer cited no patient fact.
E9 Known hypersensitivity to the ingredients in zipalertinib/placebo or any drugs similar in structure or class.
Unknown, judged by first model only
Answer cited no patient fact.
Not eligible A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19) I4 Not metI7 Not metE1 Models disagreeE2 Models disagreeE5 Models disagreeI3 UnknownI6 UnknownI8 UnknownI9 UnknownI10 UnknownI11 UnknownI12 UnknownI1 At screeningE4 At screeningAGE-MIN MetI2 MetI5 MetE3 Does not apply n/a, Intergroupe Francophone de Cancerologie Thoracique. Nearest site: Pringy, France, 29 km away. 10 questions to clarify.
Ask before referring
- I3 Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG CT-scan prior to surgery.No facts provided regarding pre-surgical imaging evaluations.
- I6 Archival tumour tissue FFPE blocks from surgery available for centrally molecular analyses.No facts provided regarding availability of archival tumour tissue blocks.
- I8 Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.No facts provided regarding investigator assessment of patient compliance capability.
- I9 Patient followed in the institution on a regular basis (every 3 to 6 months) according to standard recommendations.No facts provided regarding regular follow-up schedule at the institution.
- I10 Estimated life expectancy > 3 years.No facts provided regarding estimated life expectancy.
- I11 Woman patients who are of childbearing potential are eligible:; They must have a negative pregnancy test before the first dose of osimertinib.; They must agree to use effective methods of contraception throughout the course of treatment and should be maintained for 2 months after the end of treatment.Invalid answer 'does_not_apply'.
- I12 Male subjects who are sexually active with a woman of childbearing potential are eligible if an efficacious contraception method should be used during the treatment and during the 4 months following the last dose.No facts provided regarding sexual activity or contraception status.
- E1 History of cancer, except for the following situations: Patients with history of cancer for more than 3 years are eligible if they have been treated and considered cured. Patients with history of in situ carcinoma of the cervix or non-melanoma skin carcinoma are eligible.Writer said does not apply, checker said applies. No history of other cancers mentioned; current cancer is the primary diagnosis.
- E2 Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or other anti-cancer treatment).Writer said applies, checker said does not apply. Patient received prior osimertinib and chemotherapy, constituting prior anti-cancer treatment.
- E5 Active infection (e.g. patients receiving treatment for infection) including hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B infection except for the situations described in APPENDIX I. Screening for chronic conditions is not required.Writer said does not apply, checker said unknown. No active infection mentioned; lab values are within normal limits.
What rules the patient out
- I4 Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th edition) NSCLC.Patient has stage IV disease, not stage pIB-IIIA, and no resection mentioned.
- I7 Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treat decision; patients could receive if necessary adjuvant chemotherapy before starting osimertinib treatment.Patient has stage IV metastatic disease and prior osimertinib use, not adjuvant setting.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Signed Informed consent.
At screening, judged by code
Confirmed at screening (consent, pregnancy or protocol).
I2 Age >= 18 years.
Met, judged by both models, using F1
Patient is 73 years old, which is greater than or equal to 18.
I3 Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG CT-scan prior to surgery.
Unknown, judged by first model only
No facts provided regarding pre-surgical imaging evaluations.
I4 Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th edition) NSCLC.
Not met, judged by both models, using F2
Patient has stage IV disease, not stage pIB-IIIA, and no resection mentioned.
I5 Presence of a common EGFR mutation (Del19 or L858R).
Met, judged by both models, using F3
EGFR L858R mutation is present, which is a common EGFR mutation.
I6 Archival tumour tissue FFPE blocks from surgery available for centrally molecular analyses.
Unknown, judged by first model only
No facts provided regarding availability of archival tumour tissue blocks.
I7 Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treat decision; patients could receive if necessary adjuvant chemotherapy before starting osimertinib treatment.
Not met, judged by both models, using F2 F4
Patient has stage IV metastatic disease and prior osimertinib use, not adjuvant setting.
I8 Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.
Unknown, judged by first model only
No facts provided regarding investigator assessment of patient compliance capability.
I9 Patient followed in the institution on a regular basis (every 3 to 6 months) according to standard recommendations.
Unknown, judged by first model only
No facts provided regarding regular follow-up schedule at the institution.
I10 Estimated life expectancy > 3 years.
Unknown, judged by first model only
No facts provided regarding estimated life expectancy.
I11 Woman patients who are of childbearing potential are eligible:; They must have a negative pregnancy test before the first dose of osimertinib.; They must agree to use effective methods of contraception throughout the course of treatment and should be maintained for 2 months after the end of treatment.
Unknown, judged by first model only
Invalid answer 'does_not_apply'.
I12 Male subjects who are sexually active with a woman of childbearing potential are eligible if an efficacious contraception method should be used during the treatment and during the 4 months following the last dose.
Unknown, judged by first model only
No facts provided regarding sexual activity or contraception status.
E1 History of cancer, except for the following situations: Patients with history of cancer for more than 3 years are eligible if they have been treated and considered cured. Patients with history of in situ carcinoma of the cervix or non-melanoma skin carcinoma are eligible.
Models disagree, judged by models disagree, using F2
Writer said does not apply, checker said applies. No history of other cancers mentioned; current cancer is the primary diagnosis.
E2 Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or other anti-cancer treatment).
Models disagree, judged by models disagree, using F4 F5
Writer said applies, checker said does not apply. Patient received prior osimertinib and chemotherapy, constituting prior anti-cancer treatment.
E3 Incompletely resected NSCLC (R1 or R2).
Does not apply, judged by both models, using F2
Patient has stage IV disease, implying no surgical resection was performed.
E4 Any medical condition that would, according to the investigator's judgment, prevent the patient's participation in the clinical study.
At screening, judged by code
Confirmed at screening (consent, pregnancy or protocol).
E5 Active infection (e.g. patients receiving treatment for infection) including hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B infection except for the situations described in APPENDIX I. Screening for chronic conditions is not required.
Models disagree, judged by models disagree, using F9
Writer said does not apply, checker said unknown. No active infection mentioned; lab values are within normal limits.
Not eligible A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer I3 Not metI5 Not metE9 Applies, excludesE3 Models disagreeI4 UnknownI6 UnknownI7 UnknownI8 UnknownI9 UnknownE1 UnknownE2 UnknownE4 UnknownE6 UnknownE7 UnknownE8 UnknownAGE-MIN MetI1 MetI2 MetE5 Does not applyE10 Does not applyE11 Does not apply Phase 3, AstraZeneca. Nearest site: Lausanne, Switzerland, 51 km away. 12 questions to clarify.
Ask before referring
- I4 Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies.Facts do not specify status of other actionable driver oncogenes.
- I6 Minimum life expectancy of 12 weeks.No specific life expectancy estimate provided in facts.
- I7 Provision of acceptable tumor sample for the central testing prior to randomization.No information on provision of tumor sample for central testing.
- I8 At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at baseline and can be accurately measured at baseline as >= 10 mm in the longest diameter (except lymph nodes, which must have short axis >= 15 mm) with CT (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements.Measurable disease exists, but specific target lesion size and irradiation status unknown.
- I9 Adequate organ and bone marrow functionCreatinine clearance is low; bone marrow function and other organ values not fully specified.
- E1 As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.No information on severe or uncontrolled systemic diseases.
- E2 History of organ transplant.Answer cited no patient fact.
- E3 Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.Writer said does not apply, checker said unknown. Pneumonitis was grade 2 and resolved; no chronic immunosuppressive treatment indicated.
- E4 History of another primary malignancy except for malignancy treated with curative intent with no known active disease >= 2 years before the first dose of study intervention and of low potential risk for recurrence.Answer cited no patient fact.
- E6 Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention.Brain metastasis is asymptomatic, but stability duration and steroid use are unknown.
- E7 Active primary immunodeficiency/active infectious disease(s)Answer cited no patient fact.
- E8 Active tuberculosis infectionAnswer cited no patient fact.
What rules the patient out
- I3 Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes.Patient has a sensitizing EGFR L858R mutation, which is excluded.
- I5 WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.ECOG performance status is 2, but criterion requires 0 or 1.
- E9 Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer).Patient received prior systemic therapy (osimertinib, chemo) for advanced NSCLC.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes.
Met, judged by both models, using F2
Patient has documented non-small cell lung cancer, adenocarcinoma.
I2 Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Met, judged by both models, using F2
Diagnosis is stage IV metastatic NSCLC, not amenable to cure.
I3 Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes.
Not met, judged by both models, using F3
Patient has a sensitizing EGFR L858R mutation, which is excluded.
I4 Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies.
Unknown, judged by first model only
Facts do not specify status of other actionable driver oncogenes.
I5 WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.
Not met, judged by both models, using F7
ECOG performance status is 2, but criterion requires 0 or 1.
I6 Minimum life expectancy of 12 weeks.
Unknown, judged by first model only
No specific life expectancy estimate provided in facts.
I7 Provision of acceptable tumor sample for the central testing prior to randomization.
Unknown, judged by first model only
No information on provision of tumor sample for central testing.
I8 At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at baseline and can be accurately measured at baseline as >= 10 mm in the longest diameter (except lymph nodes, which must have short axis >= 15 mm) with CT (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements.
Unknown, judged by first model only, using F8 F10
Measurable disease exists, but specific target lesion size and irradiation status unknown.
I9 Adequate organ and bone marrow function
Unknown, judged by first model only, using F9
Creatinine clearance is low; bone marrow function and other organ values not fully specified.
E1 As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
Unknown, judged by first model only
No information on severe or uncontrolled systemic diseases.
E2 History of organ transplant.
Unknown, judged by first model only
Answer cited no patient fact.
E3 Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
Models disagree, judged by models disagree, using F11
Writer said does not apply, checker said unknown. Pneumonitis was grade 2 and resolved; no chronic immunosuppressive treatment indicated.
E4 History of another primary malignancy except for malignancy treated with curative intent with no known active disease >= 2 years before the first dose of study intervention and of low potential risk for recurrence.
Unknown, judged by first model only
Answer cited no patient fact.
E5 Presence of small cell and neuroendocrine histology components.
Does not apply, judged by both models, using F2
Histology is adenocarcinoma, not small cell or neuroendocrine.
E6 Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention.
Unknown, judged by first model only, using F10
Brain metastasis is asymptomatic, but stability duration and steroid use are unknown.
E7 Active primary immunodeficiency/active infectious disease(s)
Unknown, judged by first model only
Answer cited no patient fact.
E8 Active tuberculosis infection
Unknown, judged by first model only
Answer cited no patient fact.
E9 Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer).
Applies, excludes, judged by both models, using F4 F5
Patient received prior systemic therapy (osimertinib, chemo) for advanced NSCLC.
E10 Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
Does not apply, judged by both models, using F6
No prior exposure to anti-TIGIT or other immune-regulatory therapies.
E11 Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.
Does not apply, judged by both models, using F6
No prior treatment with anti-PD-1 or anti-PD-L1 agents.
Not eligible A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) I8 Not metI5 Models disagreeI10 Models disagreeI12 Models disagreeE1 Models disagreeE3 Models disagreeE4 Models disagreeE5 Models disagreeE6 Models disagreeE8 Models disagreeE9 Models disagreeI1 UnknownI2 UnknownI3 UnknownI6 UnknownI11 UnknownE2 UnknownE7 UnknownE10 UnknownE11 UnknownAGE-MIN MetI4 MetI7 MetI9 Met Phase 3, AbbVie. Nearest site: Bron, France, 108 km away. 19 questions to clarify.
Ask before referring
- I1 Projected life expectancy of at least 12 weeks.Life expectancy is a clinical projection not explicitly stated in the provided facts.
- I2 Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.No c-Met IHC results are provided in the patient facts.
- I3 Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.; If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).Submission of tumor material for pre-screening is a procedural step not confirmed in facts.
- I5 A known epidermal growth factor receptor (EGFR) activating mutation status. -- Participants with EGFR activating mutations are not eligibleWriter said not met, checker said met. Criterion excludes participants with EGFR activating mutations; patient has EGFR L858R.
- I6 Actionable alterations in genes other than EGFR are eligible.No information provided regarding other actionable gene alterations.
- I10 Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC; Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).; Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.; Participants with gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).Writer said not met, checker said unknown. Patient has EGFR mutation (actionable) but did not progress on platinum-based chemotherapy as required for this subgroup.
- I11 Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.Physician assessment of suitability for docetaxel is not provided.
- I12 Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:; They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day [QD] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.Writer said not met, checker said unknown. Brain metastasis is untreated, failing the 'adequate treatment' requirement.
- E1 Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.Writer said applies, checker said unknown. Patient has an untreated CNS metastasis.
- E2 Evidence of leptomeningeal disease.Answer cited no patient fact.
- E3 Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.Writer said does not apply, checker said unknown. Histology is adenocarcinoma, not adenosquamous, neuroendocrine, or sarcomatoid.
- E4 Epidermal growth factor receptor (EGFR) activating mutations.Writer said applies, checker said unknown. Patient has an EGFR activating mutation (L858R).
- E5 Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..Writer said does not apply, checker said unknown. No prior antibody-drug conjugates or c-Met targeted antibodies received.
- E6 Participants who have received prior docetaxel therapy.Writer said does not apply, checker said unknown. Prior therapies were osimertinib and carboplatin/pemetrexed, not docetaxel.
- E7 A history of other malignancies except:; Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.; Adequately treated carcinoma in situ without current evidence of disease.Answer cited no patient fact.
- E8 A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.Writer said applies, checker said unknown. History of drug-induced pneumonitis is an exclusion criterion.
- E9 Unresolved nor adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.Writer said does not apply, checker said unknown. Pneumonitis is resolved, so there is no unresolved AE >= Grade 2.
- E10 Major surgery within 21 days prior to randomization.Answer cited no patient fact.
- E11 Clinically significant condition(s) as listed in the protocol.Specific clinically significant conditions are not detailed in the facts.
What rules the patient out
- I8 An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.ECOG status is 2, but criterion requires 0 to 1.
Every criterion, as written in the registry
AGE-MIN Age at least 18 years
Met, judged by code, using F1
I1 Projected life expectancy of at least 12 weeks.
Unknown, judged by first model only
Life expectancy is a clinical projection not explicitly stated in the provided facts.
I2 Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
Unknown, judged by first model only
No c-Met IHC results are provided in the patient facts.
I3 Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.; If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
Unknown, judged by first model only
Submission of tumor material for pre-screening is a procedural step not confirmed in facts.
I4 A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
Met, judged by both models, using F2
Patient has stage IV non-squamous NSCLC, which is metastatic.
I5 A known epidermal growth factor receptor (EGFR) activating mutation status. -- Participants with EGFR activating mutations are not eligible
Models disagree, judged by models disagree, using F3
Writer said not met, checker said met. Criterion excludes participants with EGFR activating mutations; patient has EGFR L858R.
I6 Actionable alterations in genes other than EGFR are eligible.
Unknown, judged by first model only
No information provided regarding other actionable gene alterations.
I7 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Met, judged by both models, using F8
Patient has measurable disease per RECIST 1.1.
I8 An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Not met, judged by both models, using F7
ECOG status is 2, but criterion requires 0 to 1.
I9 Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
Met, judged by both models, using F5
Patient received one line of cytotoxic chemotherapy (carboplatin/pemetrexed).
I10 Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC; Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).; Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.; Participants with gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
Models disagree, judged by models disagree, using F3 F4 F5
Writer said not met, checker said unknown. Patient has EGFR mutation (actionable) but did not progress on platinum-based chemotherapy as required for this subgroup.
I11 Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
Unknown, judged by first model only
Physician assessment of suitability for docetaxel is not provided.
I12 Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:; They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day [QD] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
Models disagree, judged by models disagree, using F10
Writer said not met, checker said unknown. Brain metastasis is untreated, failing the 'adequate treatment' requirement.
E1 Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
Models disagree, judged by models disagree, using F10
Writer said applies, checker said unknown. Patient has an untreated CNS metastasis.
E2 Evidence of leptomeningeal disease.
Unknown, judged by first model only
Answer cited no patient fact.
E3 Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
Models disagree, judged by models disagree, using F2
Writer said does not apply, checker said unknown. Histology is adenocarcinoma, not adenosquamous, neuroendocrine, or sarcomatoid.
E4 Epidermal growth factor receptor (EGFR) activating mutations.
Models disagree, judged by models disagree, using F3
Writer said applies, checker said unknown. Patient has an EGFR activating mutation (L858R).
E5 Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
Models disagree, judged by models disagree, using F6
Writer said does not apply, checker said unknown. No prior antibody-drug conjugates or c-Met targeted antibodies received.
E6 Participants who have received prior docetaxel therapy.
Models disagree, judged by models disagree, using F4 F5
Writer said does not apply, checker said unknown. Prior therapies were osimertinib and carboplatin/pemetrexed, not docetaxel.
E7 A history of other malignancies except:; Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.; Adequately treated carcinoma in situ without current evidence of disease.
Unknown, judged by first model only
Answer cited no patient fact.
E8 A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
Models disagree, judged by models disagree, using F11
Writer said applies, checker said unknown. History of drug-induced pneumonitis is an exclusion criterion.
E9 Unresolved nor adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
Models disagree, judged by models disagree, using F11
Writer said does not apply, checker said unknown. Pneumonitis is resolved, so there is no unresolved AE >= Grade 2.
E10 Major surgery within 21 days prior to randomization.
Unknown, judged by first model only
Answer cited no patient fact.
E11 Clinically significant condition(s) as listed in the protocol.
Unknown, judged by first model only
Specific clinically significant conditions are not detailed in the facts.