Official Title
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
Brief Summary

The purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of patients 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.

Intermediate-size Population
Metastatic Non-Small Cell Lung Cancer

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.
Other Name: JNJ-61186372

Eligibility Criteria

Inclusion Criteria: - Has histologically or cytologically confirmed unresectable or metastatic non-small cell lung (NSCLC) cancer with an epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins), not amenable to curative therapy - Has completed prior treatment with platinum-based chemotherapy. Note: Platinum ineligible patients may qualify if treated with an alternative treatment (example, see national comprehensive cancer network [NCCN] guidelines for alternative non-platinum-based treatments) - Life expectancy is projected to be greater than or equal to (>=) 3 months with adequate hepatic, renal, pulmonary and cardiac function (physician assessed)

Exclusion Criteria: - Has medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents within the last 3 months - Has leptomeningeal disease that is active or symptomatic - Symptomatic, unstable or untreated brain metastases (need to be resolved prior to participating in the program) - Known allergies, hypersensitivity, or intolerance to amivantamab or its excipients or to other monoclonal antibodies - Is pregnant or breastfeeding

Eligibility Gender
Eligibility Age
Minimum: 18 Years

1-800-JANSSEN (1-800-526-7736)

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Janssen Research & Development, LLC
NCT Number
MeSH Terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Intervention Name