The EDC is live today — see what ships now
All studies
NCT07227025From ClinicalTrials.govRecruiting

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.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me
A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung | Trialion