Amivantamab plus olomorasib for metastatic KRAS G12C non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 trial first determines the recommended Phase 2 combination dose (RP2CD) of amivantamab and olomorasib and then tests that dose for anti-tumor activity in participants with KRAS G12C mutant metastatic NSCLC. Enrollment requires progression on or after platinum-based chemotherapy and PD‑L1‑targeted immunotherapy; Phase 1 allows additional prior therapies while Phase 2 does not. Participants must have at least one measurable lesion per RECIST 1.1 that has not been previously irradiated. Patients receive both study drugs and are monitored with imaging and safety assessments to measure tumor response and tolerability.

Why it matters

Who can join: the full rules

Inclusion criteria:

* 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 criteria:

* 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

Where it's running

• New York University Langone Medical Center
  New York, New York, United States Recruiting
• Virginia Cancer Specialists
  Fairfax, Virginia, United States Recruiting
• Princess Margaret Hospital
  Toronto, Ontario, Canada Recruiting
• The First Affiliated Hospital Sun Yat sen University
  Guangzhou, China Recruiting
• Harbin medical university cancer hospital
  Harbin, China Recruiting
• Shanghai East Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.