Trials / Approved For Marketing
Approved For MarketingNCT04599712
Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer
Pre-Approval Access With Amivantamab in Patients With Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Who Have Failed Platinum-Based Chemotherapy
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amivantamab | 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. |
Timeline
- First posted
- 2020-10-23
- Last updated
- 2025-06-13
Source: ClinicalTrials.gov record NCT04599712. Inclusion in this directory is not an endorsement.