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Double-Drug attack on tough lung cancer mutation

NCT ID NCT05375994

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether combining two targeted drugs, avutometinib and adagrasib, can shrink tumors in people with advanced non-small cell lung cancer that has a specific genetic change called KRAS G12C. Participants must have already tried a KRAS G12C inhibitor and seen their cancer worsen. The trial first finds the safest dose of the combination, then checks how well it works.

What this could mean

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

Active substance
avutometinib and adagrasib
What this could lead to
If successful, this combination could offer a new treatment option for people with KRAS G12C-mutant lung cancer whose disease has progressed after other therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the benefits and risks are not yet fully known. The combination may cause side effects or may not work for everyone.

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

12 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2026

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 subjects ≥ 18 years of age * Histologic or cytologic evidence of NSCLC * Known KRAS G12C mutation * The subject must have received prior therapy with a KRAS G12C inhibitor and experienced progression * Must have received appropriate treatment with at least one prior systemic regimen, but no more than 3 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: * Prior chemotherapy, targeted therapies, radiotherapy, immunotherapy or treatment with an investigational agent within 14 days of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C and chest radiation; within 6 months prior to Cycle 1 Day 1 for chest radiation \> 30Gy) * History of prior malignancy, with the exception of curatively treated malignancies * Major surgery within 4 weeks (excluding placement of vascular access) * Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy * Exposure to strong inhibitors of breast cancer resistance protein (BCRP) within 14 days prior to the first dose and during the course of therapy * Symptomatic brain metastases requiring steroids or other local interventions within the 2 weeks prior to initiation of therapy * 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 1 year * History of rhabdomyolysis or interstitial lung disease * Concurrent ocular disorders * Concurrent heart disease or severe obstructive pulmonary disease * Subjects with the inability to swallow oral medications

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905, United States

  • Medical College Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • UCSF Thoracic Oncology

    San Francisco, California, 94158, United States

  • University of Colorado Hospital Anschutz Cancer Pavllion

    Aurora, Colorado, 80045, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 275514, United States

  • Virginia Cancer Specialists, NEXT Oncology

    Fairfax, Virginia, 22031, United States

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