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

Part of paid clinical trials in Irvine, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06532032
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amivantamab — DRUG
    Amivantamab will be administered as IV infusion.
  • Docetaxel — DRUG
    Docetaxel will be administered as IV infusion.

Study Details

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).

Key Dates

Start date
Jul 23, 2024
Status verified
Jun 2026
Primary completion
May 29, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Phase 1: Number of Participants with Adverse events (AEs) by Severity [ Time Frame: Up to 1 year 4 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
UCI Health Irvine HospitalIrvineCalifornia92612-
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720-
University of California Irvine Medical Center Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Oncology Hematology AssociatesSpringfieldMissouri65807-
Hunterdon Hematology OncologyFlemingtonNew Jersey08822-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Irvine, CA

By research site
UCI Health Irvine Hospital· Irvine, CACancer and Blood Specialty Clinic· Los Alamitos, CAUniversity of California Irvine Medical Center Chao Family Comprehensive Cancer Center· Orange, CAOncology Hematology Associates· Springfield, MOHunterdon Hematology Oncology· Flemington, NJVirginia Cancer Specialists· Fairfax, VA

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