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A Study of Amivantamab and Olomorasib for Metastatic NSCLC

This study is testing a combination of two drugs, amivantamab and olomorasib, for people with metastatic non-small cell lung cancer (NSCLC), which is lung cancer that has spread. Specifically, it's for those whose cancer has a change in the KRAS gene called KRAS G12C. The main goals are to find the safest and most effective dose of these two drugs together, and to see how well this combination can shrink or slow down tumor growth. To join, you must have this specific KRAS G12C mutation and, for some parts of the study, your cancer must have progressed after standard chemotherapy and immunotherapy. The study plans to enroll 60 participants, but its current status is unclear.

Study design
This study is designed to find the best dose and then measure how well the treatment works. It plans to include 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects and treatment response for up to approximately 3 years and 2 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227025

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~60 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:AmivantamabOlomorasib

At a glance

Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Number of Participants with Adverse Events (AEs) by Severity
Measured over Up to approximately 3 years 2 months
+2 more outcomes measured

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

13 sites across 7 states
China3
South Korea3
Turkey (Türkiye)3
New York1
Texas1
Virginia1
Ontario1

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must have histologically or cytologically confirmed metastatic NSCLC characterized by a KRAS G12C mutation at the time of enrollment. For Phase 1: Participant must have progressed on or after, or have intolerance to, platinum-based chemotherapy and Programmed Death-Ligand 1 (PD-L1)-targeted immunotherapy given in combination or sequentially. Receipt of additional lines of prior therapy is permitted. Progression must have occurred on or after the most recent line of systemic anticancer therapy. For Phase 2: Participant must have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy given in combination or sequentially. Progression must have occurred on or after the most recent line of systemic anticancer therapy. Receipt of additional lines of prior therapy is not permitted
Participant must have at least 1 measurable lesion, according to RECIST version.1.1, that has not been previously irradiated
May have brain metastases only if previously definitively, locally treated, and participant is clinically stable and asymptomatic for greater than (\>) 2 weeks and is off or receiving low-dose corticosteroid treatment for at least 2 weeks prior to start of study treatment
Can have a prior or concurrent second malignancy (other than the disease under study) with natural history or treatment course that is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion

Participant has history of uncontrolled illness
Suspected or known allergies, hypersensitivity, or intolerance to amivantamab excipients or olomorasib excipients
Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Presence of primary driver mutations (epidermal growth factor receptor \[EGFR\], anaplastic lymphoma kinase \[ALK\], mesenchymal-epithelial transition \[MET\], human epidermal growth factor receptor 2 \[HER2\], ROS1, neurotrophic tyrosine receptor kinase \[NTRK\], B-Raf proto-oncogene \[BRAF\], rearranged during Transfection \[RET\], neuroblastoma RAS viral oncogene homolog \[NRAS\], and other KRAS mutations besides G12C) as determined by local genomic testing
Prior treatment with any KRAS inhibitor

What this trial measures

  • Phase 1: Number of Participants with Adverse Events (AEs) by SeverityUp to approximately 3 years 2 months

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade will be made by the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 defined as follows: Grade 1 (mild; asymptomatic or mild symptoms; intervention not indicated); Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3 (severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to adverse event).

  • Phase 1: Number of Participants with Dose-Limiting Toxicities (DLTs)Up to approximately 3 years 2 months

    DLT is defined as drug related adverse events and includes unacceptable non-hematologic toxicity, hematologic toxicity, pulmonary toxicity, or elevations in hepatic enzymes suggestive of drug-induced liver injury of Grade 3 or higher. Toxicities will be graded for severity according to the NCI-CTCAE, version 5.0.

  • Phase 2: Confirmed Objective Response Rate (ORR)Up to approximately 3 years 2 months

    ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by investigator review. Confirmatory analysis may be performed using Blinded Independent Central Review (BICR).