Clinical trial · Observational
Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer
Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations. The study includes two groups of people: * Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program. * Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program. The main question the study wants to answer is: How long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people? People already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025. No extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR | — | UNRESOLVED | — |
| EGFR Exon 19 Deletion Mutation | — | UNRESOLVED | — |
| EGFR Exon 20 Insertion Mutation | — | UNRESOLVED | — |
| EGFR Exon 21 Mutation | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non Small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer NSCLC | — | UNRESOLVED | — |
| Non Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- People with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.
- label
- Cohort B
- description
- People with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.
Primary outcomes (2)
- measure
- Investigator Progression Free Survival (Investigator PFS)
- timeFrame
- From the date of first dose of combination treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
- description
- The Investigator Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let at the investigator 's discretion as per local practices. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient over 18 years old * 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. * 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. * Patient covered by the French National Health Insurance system or by an approved third-party payer * 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) Exclusion Criteria: * Patient placed under legal guardianship or subject to a protective legal measure * Patient who explicitly refuses the collection or use of their personal data for research purposes * Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator
References
Publications (0)
Data not yet available