RecruitingPhase 1Phase 2NCT07227025

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

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer

Sponsor

Janssen Research & Development, LLC

Enrollment

60 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small Cell Lung

Summary

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 \[C\]).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — amivantamab and olomorasib — in people with metastatic non-small cell lung cancer (NSCLC) that has a specific gene mutation called KRAS G12C. This mutation is a target for newer therapies and this study explores combining two different targeted approaches. **You may be eligible if...** - You have advanced (metastatic) non-small cell lung cancer with a confirmed KRAS G12C mutation - You have previously received platinum-based chemotherapy and immunotherapy (PD-L1 treatment) - You have at least one measurable tumor - Your general health is good (ECOG performance status of 0 or 1) - If you have brain metastases, they must be previously treated, stable, and you must be off or on low-dose steroids **You may NOT be eligible if...** - You have not yet received standard chemotherapy and immunotherapy - You have active untreated brain metastases causing symptoms - You are in poor general health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmivantamab

Amivantamab will be administered.

DRUGOlomorasib

Olomorasib will be administered.

Locations(15)

University of California Irvine

Irvine, California, United States

New York University Langone Medical Center

New York, New York, United States

University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Oncology Consultants Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

NorthWest Medical Specialties, PLLC

Puyallup, Washington, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

The First Affiliated Hospital Sun Yat sen University

Guangzhou, China

Shanghai East Hospital

Shanghai, China

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi

Ankara, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Çankaya, Turkey (Türkiye)

Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07227025

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