Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer

Metastatic Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT04599712
• Other study ID #: CR108905
• Secondary ID: 61186372LUC4001
• Status: Approved for marketing

Study information

• Verified date: June 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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. In the case of platinum ineligible participants, the participant may qualify if previously treated with an alternative treatment (example, an investigational or approved EGFR Exon 20 targeted tyrosine kinase inhibitor [TKI], or see guidelines such as those from national comprehensive cancer network [NCCN] or European society for medical oncology [ESMO] 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-Small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC