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RECRUITING
NCT07227025
PHASE1/PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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 \[C\]).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-03

Completion Date

2029-04-30

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Amivantamab

Amivantamab will be administered.

DRUG

Olomorasib

Olomorasib will be administered.

Locations (16)

University of California Irvine

Irvine, California, United States

New England Cancer Specialists

Topsham, Maine, 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)