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RECRUITING Phase 1

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

NCT07227025 · View on ClinicalTrials.gov ↗

Study Summary

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 \[C\]).

Interventions

  • DRUG Olomorasib
  • DRUG Amivantamab

Study Locations (16)

Other

  • The First Affiliated Hospital Sun Yat sen University — Guangzhou
  • Shanghai East Hospital — Shanghai
  • Severance Hospital Yonsei University Health System — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul
  • Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi — Ankara
  • Ankara Bilkent Sehir Hastanesi — Çankaya
  • Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi — Istanbul

California

  • University of California Irvine — Irvine

Maine

  • New England Cancer Specialists — Topsham

New York

  • New York University Langone Medical Center — New York

Pennsylvania

  • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine — Philadelphia

Texas

  • Oncology Consultants Cancer Center — Houston

Virginia

  • Virginia Cancer Specialists — Fairfax

Washington

  • NorthWest Medical Specialties, PLLC — Puyallup

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2026-03-03
Est. Completion 2029-04-30
Phase Phase 1

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07227025

The ClinicalTrials.gov registry entry for NCT07227025 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 2 interventions — of which Olomorasib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07227025 reports 16 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Maine. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07227025 about?

NCT07227025 is a clinical study titled "A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer". 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 ...

What is the current status of trial NCT07227025?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-03-03. Estimated completion is 2029-04-30.

What conditions does trial NCT07227025 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07227025?

The interventions under investigation include: Olomorasib (DRUG), Amivantamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07227025?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07227025 being conducted?

This trial has 16 study locations across California, Maine, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial