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New drug cocktail targets tough lung cancer mutation

NCT ID NCT05054725

Disease control Sponsor: Revolution Medicines, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a combination of two oral drugs, RMC-4630 and sotorasib, in 47 adults with advanced KRASG12C-mutant non-small cell lung cancer that had progressed after standard treatments. The goal was to see if the combination could shrink tumors. The study is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RMC-4630 and sotorasib (two oral drugs)
What this could lead to
If successful, this combination could offer a new treatment option for people with a specific type of advanced lung cancer that has stopped responding to other therapies.
What could go wrong
This is a small, early-phase trial with only 47 participants, so results may not apply to everyone. The drugs may cause side effects or fail to shrink tumors in many patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

47 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject must be ≥18 years of age. * Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed) Exclusion Criteria * Primary central nervous system (CNS) tumors * Known or suspected leptomeningeal or brain metastases or spinal cord compression * Clinically significant cardiac disease * Known impairment of GI function that would alter the absorption * Active autoimmune disease requiring systemic treatment within past 2 years * History of severe allergic reactions to any of the study intervention components * Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment. * Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor

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Conditions

The condition(s) this trial relates to.

bronchial neoplasm carcinoma hereditary sensory and autonomic neuropathy lung disorder lung neoplasm neoplasm Neoplasms by Site non-small cell lung carcinoma respiratory system disorder respiratory tract neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • APHM Hopital Nord, Service d'Oncologie Multidisciplinaire et innovations therapeutics

    Marseille, 13015, France

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios Fachkliniken Munchen

    Gauting, Bavaria, 82131, Germany

  • Azienda Ospedaliera dei Colli

    Naples, Campania, 80131, Italy

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • BRCR Medical Center Inc.

    Plantation, Florida, 33322, United States

  • Bethanien Hospital Moers

    Moers, North Rhine-Westphalia, 47441, Germany

  • Blacktown Hospital

    Blacktown, 2148, Australia

  • CHRISTUS St. Michael-Colom and Carney Clinic P.A

    Texarkana, Texas, 75503, United States

  • Cancer Specialists of North Florida

    Saint Augustine, Florida, 32086, United States

  • Charite Benjamin Franklin Comprehensive Cancer center

    Berlin, 12200, Germany

  • Charleston Oncology

    Charleston, South Carolina, 29414, United States

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Clinical Research Alliance, Inc.

    New York, New York, 10021, United States

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, Galicia, 15006, Spain

  • Comprehensive Cancer Center Mainfranken, University Wuerzburg

    Homburg, Saarland, 66421, Germany

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • E-DA Hospital

    Kaohsiung City, 824, Taiwan

  • Evangelische Lung Clinic

    Berlin, 13125, Germany

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901, United States

  • GenHarp Clinical Solutions

    Evergreen Park, Illinois, 60805, United States

  • Goulburn Valley Health

    Shepparton, 3630, Australia

  • Hamato-Onkologie Hamburg

    Hamburg, 20251, Germany

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70809, United States

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Larrey Universite Paul Sabatier

    Toulouse, 31059, France

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026, Spain

  • Istituto Europeo Di Oncologia

    Milan, 20141, Italy

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

  • Lung Cancer Center, University of Saarland

    Homburg, Saarland, 66421, Germany

  • Lungenklinik Hemer

    Hemer, North Rhine-Westphalia, 58675, Germany

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044, United States

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404, United States

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • New England Cancer Specialists

    Scarborough, Maine, 04074, United States

  • New Jersey Center for Cancer Research

    Brick, New Jersey, 08724, United States

  • Northwest Cancer specialists, P.C.

    Vancouver, Washington, 98684, United States

  • POIS Sachsen GmbH

    Leipzig, Saxony, 04347, Germany

  • Roswell Park cancer Institute

    Buffalo, New York, 14263, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • South West Oncology

    Warrnambool, Victoria, 3280, Australia

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Tennessee Oncology

    Chattanooga, Tennessee, 37404, United States

  • The Christie NHS Foundation Trust

    Manchester, Greater Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT, United Kingdom

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • William Osler Health System

    Mississauga, Ontario, L5N 5M8, Canada

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219, United States

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