A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05488314
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Capmatinib — DRUG
    Capmatinib will be administered orally.
  • Amivantamab — DRUG
    Amivantamab will be administered as IV infusion.

Study Details

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).

Key Dates

Start date
Dec 13, 2022
Status verified
Jun 2026
Primary completion
Jun 9, 2026
Completion
Apr 28, 2027

Study Design

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

Arms

  • Experimental: Phase 1 (Combination Dose Selection)
    Participants will receive capmatinib 400 milligrams (mg) orally twice daily from Cycle 1 Day 1, in combination with amivantamab 700 mg intravenous (IV) infusion (for body weight less than 80 kilograms \[kg\]) or 1050 mg IV infusion (for body weight greater than or equal to 80 kg) once weekly from Cycle 1 Day 1 for 4 weeks and then every 2 weeks from Week 5 (Cycle 2; each cycle of 28 days). 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 by the study evaluation team (SET).
  • Experimental: Phase 2 (Dose Expansion)
    Participants with mesenchymal-epithelial transition (MET) exon 14 skipping mutation who are treatment naïve (Cohort 1A), who have received prior therapy (Cohort 1B), or participants with MET amplification who have received prior therapy (Cohort 1C) will receive capmatinib in combination with amivantamab at the RP2CD determined by the SET in Phase 1.

Primary Outcome Measure

Phase 1: Number of Participants with Adverse events (AEs) by Severity [ Time Frame: Up to 2 years 1 month ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham, Comprehensive Cancer CenterBirminghamAlabama35233-
The Oncology Institute of Hope and InnovationCerritosCalifornia90703-
UCLALos AngelesCalifornia90095-
Montefiore Einstein Center for Cancer CareThe BronxNew York10467-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham, Comprehensive Cancer Center· Birmingham, ALThe Oncology Institute of Hope and Innovation· Cerritos, CAUCLA· Los Angeles, CAMontefiore Einstein Center for Cancer Care· The Bronx, NYVirginia Cancer Specialists· Fairfax, VA

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