Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer
Official title: Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program
Run by Groupe Francais De Pneumo-Cancerologie · NCT07563205 · Data updated 2026-11-12
This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Groupe Francais De Pneumo-Cancerologie Academic / other |
| Drugs / interventions | amivantamab, osimertinib, chemotherapy |
| Locations | 16 sites (Aix-en-Provence and 15 other locations) |
| Status | Recruiting |
| Started | November 19, 2025 |
| Main results expected | November 19, 2027 |
| Study ends | November 19, 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07563205 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with metastatic NSCLC who have an EGFR exon 20 insertion receiving amivantamab plus platinum chemotherapy in first line, or adults with EGFR exon 19 or 21 mutations receiving the combination after osimertinib, and who are covered by French National Health Insurance or an approved payer.
✕Probably not a fit
Patients without the specified EGFR mutations, those with earlier-stage disease, or people not receiving amivantamab through the early access program are unlikely to be eligible or to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study collects real-world outcomes from adults with metastatic NSCLC who receive amivantamab plus platinum-based chemotherapy through an early access program. It enrolls two cohorts: Cohort A includes patients with EGFR exon 20 insertions treated with the combination as first-line therapy, and Cohort B includes patients with EGFR exon 19 or 21 mutations treated with the combination after prior osimertinib. Investigators will record time to disease progression (progression-free survival), other clinical outcomes, and safety events using routine clinical data. The study is non-randomized and aims to describe effectiveness and tolerability across participating French hospitals.
Why it matters
Potential benefit: If successful, the study could show that adding amivantamab to chemotherapy helps people with EGFR-mutant metastatic NSCLC stay progression-free longer and clarify the combination's real-world safety.
How similar studies have gone: Prior clinical trials have shown activity of amivantamab in EGFR exon 20–mutant NSCLC, but combining amivantamab with platinum chemotherapy in these exact real-world settings is less well documented and is the focus of this observational effort.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CH du Pays d Aix - Service des Maladies Respiratoires
Aix-en-Provence, France Recruiting -
APHP Hôpital Avicennes
Bobigny, France Recruiting -
Pneumologie Centre Hospitalier Intercommunal de Créteil
Créteil, France Recruiting -
Hôpital A. Mignot
Le Chesnay, France Recruiting -
Pneumologie Hôpital Calmette
Lille, France Recruiting -
Pneumologie Hôpital privé Jean Mermoz
Lyon, France Recruiting
Show 10 more locations
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Centre Léon Bérard
Lyon, France Recruiting -
Hôpital Nord
Marseille, France Recruiting -
CH de la Région d'Annecy - Service de Pneumologie
Pringy, France Recruiting -
Pneumologie CHU St Etienne
Saint-Etienne, France Recruiting -
CHU La Réunion Site Sud
Saint-Pierre, France Recruiting -
Hôpital Louis Pradel
Bron, France Active not recruiting -
Pneumologie Centre François Baclesse
Caen, France Active not recruiting -
CHRU de Nancy
Nancy, France Active not recruiting -
Centre Antoine Lacassagne
Nice, France Active not recruiting -
Institut Curie
Paris, France Active not recruiting
Study contacts
- Principal investigator: Prof. Jean-Bernard Auliac — Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil
- Study coordinator: Prof. Laurent Greillier
- Email: a.boucheix@g-f-p-c.org
- Phone: +33 4 73 98 39 86
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC
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-
Understanding resistance to amivantamab in lung cancer patients
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SI-B036 safety test in advanced and metastatic solid tumors
This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.
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Befotertinib plus chemo with MRD-guided escalation for EGFR-mutant NSCLC
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.