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New drug cocktail targets tough lung cancer mutation

NCT ID NCT07339839

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1/2

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

Participants

About 42 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

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

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: * 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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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