Status:
ACTIVE_NOT_RECRUITING
A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 can...
Eligibility Criteria
Inclusion
- 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 (\<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment
- May have a prior malignancy (other than the disease under study) if the natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Have an ECOG performance status of 0 or 1
Exclusion
- For Phase 2 only: Participant has known oncogenic driver mutations (EGFR, MET, HER2, ALK, ROS1, NTRK, BRAF, RET, or KRAS) as detected by local testing or by central ctDNA testing
- Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment
- Participant has: a.(Or has a history of) leptomeningeal disease (carcinomatous meningitis); b. Spinal cord compression not definitively treated with surgery or radiation.
- Medical history of (non-infectious) ILD/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening- Participant has history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia) or has known allergies, hypersensitivity, or intolerance to: a. amivantamab or amivantamab excipients (refer to the amivantamab IB); b.docetaxel, docetaxel excipients or to other drugs formulated with polysorbate and paclitaxel
Key Trial Info
Start Date :
July 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06532032
Start Date
July 23 2024
End Date
June 9 2026
Last Update
December 5 2025
Active Locations (15)
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1
UCI Health Irvine Hospital
Irvine, California, United States, 92612
2
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
3
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
4
Oncology Hematology Associates
Springfield, Missouri, United States, 65807