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New drug combo targets hard-to-treat lung cancer mutation

NCT ID NCT05074810

Disease control Sponsor: Verastem, 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining two or three drugs can help people with a specific genetic subtype of non-small cell lung cancer (KRAS G12C). The drugs aim to block cancer growth signals. About 153 adults who have or haven't received prior KRAS-targeting therapy will take part. The goal is to see if the combination shrinks tumors and is safe, but ongoing treatment is needed to control the disease.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

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: * Male or female patients ≥ 18 years of age * Histologic or cytologic evidence of NSCLC * Known KRAS G12C mutation * Either exposed or not exposed to a KRAS inhibitor to be included in Part A (avutometinib + sotorasib + defactinib) and not exposed to KRAS inhibitor to be included in Part B (avutometinib + sotorasib + defactinib), Cohort 1 * Received at least 1 dose of a G12C inhibitor to be included in Part B, Cohort 2 (avutometinib + sotorasib + defactinib) * Must have received appropriate treatment with at least one prior systemic regimen, but no more than 2 prior regimens, for Stage 3B-C or 4 NSCLC * Measurable disease according to RECIST 1.1 * An Eastern Cooperative Group (ECOG) performance status ≤ 1 * Adequate organ function * Adequate recovery from toxicities related to prior treatments * Agreement to use highly effective method of contraceptive Exclusion Criteria: * Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy * History of prior malignancy, with the exception of curatively treated malignancies * Major surgery within 4 weeks, minor surgery within 2 weeks (excluding placement of vascular access) * History of treatment with a direct and specific inhibitor of MEK * Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy * Symptomatic brain metastases requiring steroids or other local interventions. * Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy * Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active * Active skin disorder that has required systemic therapy within the past year * History of rhabdomyolysis * Concurrent ocular disorders * Concurrent heart disease or severe obstructive pulmonary disease * Inability to swallow oral medications * Female patients that are pregnant or breastfeeding * Previously treated with sotorasib and were dose reduced due to toxicity

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

KRAS activating mutation Non-small cell lung cancer

Contacts and locations

Locations

  • Alliance Cancer Specialists,

    Horsham, Pennsylvania, 19044, United States

  • CHRU of Lille

    Lille, 59037, France

  • CHU de Liège

    Liège, 4000, Belgium

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195, United States

  • Consultants in Medical Oncology & Hematology

    Broomall, Pennsylvania, 19008, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Teresa Herrera (C.H.U.A.C)

    A Coruña, 15006, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario Virgen De La Victoria

    Málaga, 29010, Spain

  • Hospital Universitario Virgen de la Macarena

    Seville, 41009, Spain

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Foch

    Suresnes, 92150, France

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005, United States

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • Maryland Oncology & Hematology, P.A.

    Rockville, Maryland, 20850, United States

  • MedStar Washington Hospital Center, MedStar Georgetown Cancer Institute,

    Washington D.C., District of Columbia, 20010, United States

  • Minnesota Oncology Hematology, P.A

    Woodbury, Minnesota, 55125, United States

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684, United States

  • Ohio State University Brain and Spine Hospital

    Columbus, Ohio, 43210, United States

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060, United States

  • Rocky Mountain Cancer Center, LLP

    Boulder, Colorado, 80303, United States

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Texas Oncology

    Austin, Texas, 78731, United States

  • Texas Oncology

    Longview, Texas, 75601, United States

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104, United States

  • University Hospital Gent

    Ghent, 9000, Belgium

  • University of Leicester

    Leicester, LE2 7LX, United Kingdom

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.