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Completed
NCT06532032
A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
Conditions: Carcinoma, Non-Small-Cell Lung
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 12
Sponsor: Janssen Research & Development, LLC
Location: UCI Health Irvine Hospital Irvine California
Summary
The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and docetaxel combination therapy in participants with metastatic non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC without oncogenic driver mutations with disease progression on platinum-based chemotherapy and immune checkpoint inhibitor, in the Phase 2 (expansion).
Eligibility Criteria
Inclusion Criteria:
* Participant must have histologically or cytologically confirmed NSCLC and must have metastatic NSCLC at the time of enrollment
* Participant must have at least 1 measurable lesion, according to RECIST v1.1, that has not been previously irradiated
* May have brain metastases only if previously definitively treated, and participant is clinically stable and asymptomatic for \>2 weeks and is off or receiving low-dose corticosteroid treatment (\
Source: ClinicalTrials.gov (NCT06532032). StuddyBuddy aggregates publicly available trial information.