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New drug duo targets tough lung cancer mutation

NCT ID NCT07164170

Disease control Sponsor: Abbisko Therapeutics Co, Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This phase 2 trial tests a combination of two drugs, ABSK043 and glecirasib, in people with advanced non-small cell lung cancer that has a specific genetic change called KRAS G12C. The study will enroll 86 participants to see if the combination is safe and can shrink tumors. It is currently recruiting.

What this could mean

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

Active substance
ABSK043 combined with glecirasib
What this could lead to
If successful, this combination could offer a new treatment option for people with a specific genetic mutation in advanced lung cancer.
What could go wrong
This is an early-phase trial with only 86 participants, so results may not apply to everyone. The combination may cause side effects or fail to shrink tumors.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 86 people

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

Started

Sep 2025

Expected to finish

Jul 2029

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: 1. Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form. 2. Gender was not limited patients aged ≥18 years at the time of signing the informed consent. 3. Histologically or cytologically confirmed locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC). For patients in the dose-escalation cohort (Part A) of the escalation part: Patients must have experienced disease progression following at least one line of prior standard systemic therapy, but no more than two lines of systemic therapy. For patients in the dose confirmation cohort (Part B) of the escalation part : 1. Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A); 2. Documented or central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) . For patients in the expansion cohort of the expansion part : 1. Patients who have not received prior systemic therapy for locally advanced or unresectable/metastatic disease; 2. Central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) . 4. Tumor tissue or blood test report confirmed KRASG12C mutation. 5. Patients must have at least one measurable lesion as defined by RECIST v1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1. 7. Expected survival time of ≥3 months. 8. Patients must have adequate organ and bone marrow function. Exclusion Criteria: 1. Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components. 2. Toxicities from prior antitumor therapy have not returned to baseline or stabilized. 3. Patients with active brain metastases. 4. The patient currently has active interstitial lung disease. 5. Patients currently have active autoimmune disease or a history of autoimmune disease that may be at risk for recurrence. 6. Any condition requiring systemic treatment with corticosteroids. 7. Uncontrolled or significant cardiovascular disease. 8. Has a known human immunodeficiency virus (HIV) infection that is not well controlled. 9. Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study

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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.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Central Hospital Affiliated to Shangdong First Medical University

    NOT_YET_RECRUITING

    Jinan, Shangdong, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institude

    NOT_YET_RECRUITING

    Nanning, Guangxi, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • Hunan Cancer Hospitial

    RECRUITING

    Changsha, Hunan, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • The First Affiliated Hospital of Anhui Medical University

    NOT_YET_RECRUITING

    Hefei, Anhui, China

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi’an, Shanxi, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • Tongji Hospital Tongji Medical College of Hust

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • West China Hospital Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Zhongda Hospital Southeast University

    RECRUITING

    Nanjing, Jiangsu, China

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