Actively Recruiting
A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
60
Participants Needed
15
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of amivantamab and olomorasib to find the best dose for treating metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. This study aims to see how well this combination therapy can slow or stop tumor growth in patients whose cancer has spread to other parts of the body and who have previously undergone certain cancer treatments. The trial includes both phase 1 to determine the recommended dose and phase 2 to further evaluate the treatment's effects. Participants will receive amivantamab along with olomorasib until their disease progresses, they experience significant side effects, or they meet other criteria to stop treatment. After phase 1 determines the best dose, phase 2 participants will continue with this dose. Eligible participants may also have the option to enter a long-term extension phase to keep receiving the study treatments beyond the initial treatment period. During the trial, researchers will monitor participants closely for side effects, treatment tolerability, and how the tumors respond to therapy using standard measures. They will track adverse events, dose-limiting toxicities, and tumor response rates for up to about three years and two months. Other outcomes include duration of response, disease control rate, progression-free survival, and overall survival. This comprehensive monitoring helps assess the safety and effectiveness of the combination therapy over time.
CONDITIONS
Brief 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...
- Have metastatic non-small cell lung cancer with a confirmed KRAS G12C mutation
- For Phase 1: Have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy given together or one after the other; additional prior therapies allowed
- For Phase 2: Have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy; no additional prior therapies allowed
- Have at least one measurable tumor lesion not previously treated with radiation
- May have brain metastases if previously treated, stable, and asymptomatic for more than 2 weeks with low or no corticosteroids
- May have a second cancer unlikely to affect study outcomes
- Have an ECOG performance status of 0 or 1
You will not qualify if you...
- Have a history of uncontrolled illness
- Have known allergies or intolerance to amivantamab or olomorasib ingredients
- Have or had non-infectious interstitial lung disease or pneumonitis, or suspected cases not ruled out by imaging
- Have other primary driver mutations besides KRAS G12C as identified by genomic testing
- Have had prior treatment with any KRAS inhibitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression, significant toxicity, or discontinuation criteria are met
Participants receive amivantamab and olomorasib combination therapy to determine the recommended phase 2 combination dose and then continue treatment until disease progression, significant toxicity, or other criteria for discontinuation are met.
Regular visits during treatment (frequency per protocol)
Duration - Up to approximately 3 years and 2 months
Participants who discontinue treatment are followed for safety and efficacy outcomes.
Periodic visits during follow-up
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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