A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 60
- Started
- 3 March 2026
- Main results due
- 30 November 2028
- Study sites
- 12
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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 \[C\]).
Study sites(12)
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
Severance Hospital Yonsei University Health System
Seoul, South Korea
Recruiting
Asan Medical Center
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
Ankara, Turkey (Türkiye)
Recruiting
Ankara Bilkent Sehir Hastanesi
Çankaya, Turkey (Türkiye)
Recruiting
Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
Istanbul, Turkey (Türkiye)
Recruiting
Showing 12 of 12 sites. 12 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07227025. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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