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

Part of paid clinical trials in Irvine, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07227025
Phase
PHASE1/PHASE2
Status
Recruiting
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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.
  • Olomorasib — DRUG
    Olomorasib will be administered.

Study Details

The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose \[RP2CD\]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation \[change\] in the kirsten rat sarcoma viral oncogene homolog \[KRAS\] gene in tumor cells in which glycine \[G\] at position 12 is replaced with cystine \[C\]).

Key Dates

Start date
Mar 3, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Combination Dose Selection
    Participants will receive amivantamab along with olomorasib to determine the RP2CD of the combination therapy until disease progression, significant toxicity, or until another criterion for discontinuation of study treatment is met. Eligible participants may have the option to transfer to a long-term extension (LTE) phase for continued access to study treatments.
  • Experimental: Phase 2: Expansion
    Participants will receive amivantamab and olomorasib combination therapy at the RP2CD determined in Phase 1 until disease progression, significant toxicity, or until another criterion for discontinuation of study treatment is met. Eligible participants may have the option to transfer to LTE phase for continued access to study treatments.

Primary Outcome Measure

Phase 1: Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to approximately 3 years 2 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California IrvineIrvineCalifornia92697-
New York University Langone Medical CenterNew YorkNew York10016-
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
Oncology Consultants Cancer CenterHoustonTexas77030-
Virginia Cancer SpecialistsFairfaxVirginia22031-
NorthWest Medical Specialties, PLLCPuyallupWashington98373-

Find similar trials in Irvine, CA

By research site
University of California Irvine· Irvine, CANew York University Langone Medical Center· New York, NYUniversity of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine· Philadelphia, PAOncology Consultants Cancer Center· Houston, TXVirginia Cancer Specialists· Fairfax, VANorthWest Medical Specialties, PLLC· Puyallup, WA

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