Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer
NCT04599712 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2025-06-13
Summary
The purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. This intermediate EAP may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.
Conditions
- Metastatic Non-Small Cell Lung Cancer
Interventions
- DRUG
-
Amivantamab will be administered intravenously at the recommended doses based on weight (1050 milligram \[mg\] or 1400 mg) once weekly for the first 4 week cycle (1 cycle equals to 28 days), then every 2 weeks thereafter.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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