← Back to all trials
Active Not Recruiting
NCT05488314
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable 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: 57
Sponsor: Janssen Research & Development, LLC
Location: University of Alabama at Birmingham, Comprehensive Cancer Center Birmingham Alabama
Summary
The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD\[s\]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).
Eligibility Criteria
Inclusion Criteria:
* Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)
* May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (\>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \[\10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms
* Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment
Source: ClinicalTrials.gov (NCT05488314). StuddyBuddy aggregates publicly available trial information.