A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

NCT ID: NCT06532032

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-23
• Study Completion Date: 2026-06-09

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 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).

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 (Combination Dose Selection)

Participants will receive amivantamab intravenous (IV) infusion administered based on body weight from Cycle 1 Day 1, Day 2, and subsequent doses on Days 8 and 15, and then on Day 1 of each 21-day treatment cycle. Docetaxel will be administered on Day 2 of Cycle 1 (before Day 2 amivantamab infusion) and then on Day 1 of each 21-day treatment cycle, thereafter. Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met.

Group Type: EXPERIMENTAL

Amivantamab

Intervention Type: DRUG

Amivantamab will be administered as IV infusion.

Docetaxel

Intervention Type: DRUG

Docetaxel will be administered as IV infusion.

Phase 2 (Dose Expansion)

Participants will receive amivantamab in combination with docetaxel in 2 cohorts (Cohort A \[adenocarcinoma\] and Cohort B \[squamous\]) at the RP2CD determined in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met.

Group Type: EXPERIMENTAL

Amivantamab

Intervention Type: DRUG

Amivantamab will be administered as IV infusion.

Docetaxel

Intervention Type: DRUG

Docetaxel will be administered as IV infusion.

Interventions

Amivantamab

Amivantamab will be administered as IV infusion.

Intervention Type: DRUG

Docetaxel

Docetaxel will be administered as IV infusion.

Intervention Type: DRUG

Other Intervention Names

JNJ-61186372; TAXOTERE

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 (<=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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research &Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

UCI Health Irvine Hospital

Irvine, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

University of California Irvine Medical Center Chao Family Comprehensive Cancer Center

Orange, California, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Hunterdon Hematology Oncology

Flemington, New Jersey, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Changhua Christian Hospital

Changhua, , Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Chi Mei Medical Center Liu Ying

Liou Ying Township, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University

Taipei, , Taiwan

Ankara Bilkent Sehir Hastanesi

Çankaya, , Turkey (Türkiye)

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

The Royal Marsden NHS Trust

Sutton, , United Kingdom

Countries

United States; Taiwan; Turkey (Türkiye); United Kingdom

Other Identifiers

61186372PANSC2003

Identifier Type: OTHER

Identifier Source: secondary_id

61186372PANSC2003

Identifier Type: -

Identifier Source: org_study_id