New drug cocktail targets tough lung cancer mutation
NCT ID NCT07339839
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing a combination of two drugs—a targeted pill (Glecirasib) and an immunotherapy infusion (Ivonescimab)—as a first treatment for people with advanced non-small cell lung cancer that has a specific KRAS G12C mutation. The study will first find the safest dose of the combo, then check if it can shrink tumors. It involves 42 participants across multiple centers in China.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Glecirasib (a targeted pill) and Ivonescimab (an immunotherapy infusion)
- What this could lead to
- If it works, this could offer a new first-line treatment option for people with a specific type of advanced lung cancer (KRAS G12C mutation).
- What could go wrong
- This is a very early, small trial (Phase 1/2) with only 42 participants. The combination may cause serious side effects or fail to shrink tumors effectively.
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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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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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.
Show the full entry requirements Hide 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: * Signed written informed consent. * Age ≥18 years. * Newly diagnosed, unresectable, locally advanced (ineligible for curative concurrent - chemoradiotherapy) or metastatic NSCLC per AJCC 9th edition. * KRAS G12C mutation confirmed by validated testing. * PD-L1 TPS ≥1%. * ≥1 measurable lesion per RECIST v1.1. * No prior systemic therapy for advanced/metastatic NSCLC; prior adjuvant therapy allowed if completed \>6 months before dosing and toxicities recovered to ≤Grade 1. * ECOG PS 0-2. * Life expectancy \>3 months * Adequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds) * Negative pregnancy test for women of childbearing potential; adequate contraception for men and women through 3 months post-treatment * Willing and able to comply with study procedures and follow-up. Exclusion Criteria: * History of other malignancies (exceptions: cured basal cell carcinoma, cervical carcinoma in situ) * Predominant squamous NSCLC, small cell carcinoma, or neuroendocrine carcinoma. * Other actionable drivers (EGFR, ALK, ROS1, RET, BRAF, NTRK, MET, etc.). * Known hypersensitivity to study drugs. * Prior PD-1/PD-L1 inhibitors or KRAS inhibitors. * Active autoimmune disease or autoimmune disease history requiring systemic therapy. * Systemic immunosuppressive therapy within 14 days prior to first dose. * Symptomatic ascites/pleural effusion needing recurrent drainage. * Significant cardiovascular disease (NYHA ≥2, MI within 1 year, uncontrolled arrhythmias). * Active infection, unexplained fever \>38.5°C. * Interstitial lung disease or pneumonitis. * HIV infection or other immunodeficiency. * Live vaccines within 4 weeks. * Substance abuse, alcoholism, or psychiatric disorders impairing compliance. * Unable to swallow oral medication. * Any condition that may interfere with study participation or interpretation as judged by investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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