Actively Recruiting
A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
60
Participants Needed
15
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 \[C\]).
CONDITIONS
Official Title
A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic NSCLC with KRAS G12C mutation at enrollment
- For Phase 1: Progressed on or after platinum-based chemotherapy and PD-L1 immunotherapy; additional prior therapies allowed
- For Phase 2: Progressed on or after platinum-based chemotherapy and PD-L1 immunotherapy; no additional prior therapies allowed
- At least one measurable lesion per RECIST version 1.1, not previously irradiated
- Brain metastases allowed if previously treated, stable, asymptomatic for more than 2 weeks, and off or on low-dose corticosteroids for at least 2 weeks before treatment
- Prior or concurrent second malignancy allowed if unlikely to interfere with study endpoints
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- History of uncontrolled illness
- Known or suspected allergies or intolerance to amivantamab or olomorasib excipients
- History or current non-infectious interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis not ruled out by imaging
- Presence of primary driver mutations other than KRAS G12C, including EGFR, ALK, MET, HER2, ROS1, NTRK, BRAF, RET, NRAS, or other KRAS mutations
- Prior treatment with any KRAS inhibitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of California Irvine
Irvine, California, United States, 92697
Suspended
2
New York University Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
3
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Suspended
4
Oncology Consultants Cancer Center
Houston, Texas, United States, 77030
Suspended
5
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
6
NorthWest Medical Specialties, PLLC
Puyallup, Washington, United States, 98373
Suspended
7
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
8
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China, 510060
Actively Recruiting
9
Shanghai East Hospital
Shanghai, China, 310000
Actively Recruiting
10
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
11
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
12
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
13
Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
Ankara, Turkey (Türkiye), 06620
Actively Recruiting
14
Ankara Bilkent Sehir Hastanesi
Çankaya, Turkey (Türkiye), 06800
Actively Recruiting
15
Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here