NCT07563205 Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer
| NCT ID | NCT07563205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GFPC Investigation |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2027-11-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-11-19 with a primary completion date of 2027-11-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Prof. Jean-Bernard Auliac
PRINCIPAL INVESTIGATOR
Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil
Frequently Asked Questions
Who can join the NCT07563205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563205 currently recruiting?
Yes, NCT07563205 is actively recruiting participants. Contact the research team at a.boucheix@g-f-p-c.org for enrollment information.
Where is the NCT07563205 trial being conducted?
This trial is being conducted at Aix-en-Provence, France, Bobigny, France, Bron, France, Caen, France and 11 additional locations.
Who is sponsoring the NCT07563205 clinical trial?
NCT07563205 is sponsored by GFPC Investigation. The principal investigator is Prof. Jean-Bernard Auliac at Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil. The trial plans to enroll 100 participants.
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