A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
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).
Checked against the public recordLast updated Jul 31, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Janssen Research & Development, LLC
- Interventions being studied
- Drug: Amivantamab; Drug: Docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 (\<=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 Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCI Health Irvine HospitalIrvine, California
- Cancer and Blood Specialty ClinicLos Alamitos, California
- University of California Irvine Medical Center Chao Family Comprehensive Cancer CenterOrange, California
- Oncology Hematology AssociatesSpringfield, Missouri
- Hunterdon Hematology OncologyFlemington, New Jersey
- Virginia Cancer SpecialistsFairfax, Virginia
- Changhua Christian HospitalChanghua
- Kaohsiung Medical University HospitalKaohsiung City
- Chi Mei Medical Center Liu YingLiou Ying Township
- Taichung Veterans General HospitalTaichung
- National Taiwan University HospitalTaipei
- Taipei Medical UniversityTaipei
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2026. Always confirm current availability with the study team.