Double-Drug attack on tough lung cancer mutation
NCT ID NCT05375994
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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12 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Jun 2026
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Mayo Clinic Cancer Center
Jacksonville, Florida, 32224, United States
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Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
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Medical College Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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UCSF Thoracic Oncology
San Francisco, California, 94158, United States
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University of Colorado Hospital Anschutz Cancer Pavllion
Aurora, Colorado, 80045, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 275514, United States
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Virginia Cancer Specialists, NEXT Oncology
Fairfax, Virginia, 22031, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Can a video game teach cancer patients to tame their pain?