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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT04599712
Other study ID # CR108905
Secondary ID 61186372LUC4001
Status Approved for marketing
Phase
First received
Last updated

Study information

Verified date June 2021
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
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
Est. completion date
Est. primary completion date
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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