Can a Two-Drug combo outsmart resistant lung cancer?

NCT ID NCT07109531

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether a combination of two targeted drugs, ASKC202 and limertinib, can help people with advanced non-small cell lung cancer (NSCLC) whose tumors have a specific genetic change (MET amplification/overexpression) and have stopped responding to earlier EGFR inhibitor treatment. Participants will be randomly assigned to receive either the drug combination or standard platinum-based chemotherapy. The main goal is to see if the combination delays cancer progression better than chemotherapy.

What this could mean

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

Active substance
ASKC202 combined with limertinib (oral targeted therapy)
What this could lead to
If successful, this combination could offer a new targeted treatment option for people with advanced lung cancer whose tumors have stopped responding to standard EGFR inhibitor therapy.
What could go wrong
This is a phase 3 trial, but results are not yet known. The combination may not improve outcomes compared to chemotherapy, and it could cause side effects like other targeted therapies.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 286 people

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

Started

Aug 2025

Expected to finish

Dec 2028

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. Willing and able to provide signed and dated informed consent; 2. Patients at least 18 years of age; 3. Locally advanced or metastatic non-small cell lung cancer (NSCLC); 4. Objective disease progression following prior EGFR-TKI therapy; 5. EGFR mutation with MET amplification/Overexpression by a central laboratory; 6. Measurable lesions based on RECIST 1. 1; 7. ECOG performance status 0 or 1; 8. Expected survival \>12 weeks; 9. Adequate bone marrow reserve or organ function. Exclusion Criteria: 1. Prior or ongoing treatment with any c-Met target; 2. Previously received systemic chemotherapy; 3. Patients requiring continuous use of systemic immunosuppressants or systemic corticosteroids within 2 weeks prior to the first dose. 4. Patients who underwent other major surgical procedures other than diagnosis or biopsy within 4 weeks prior to the first dose, or who were expected to undergo major surgeries during the study period; 5. Prior to the first administration, there are unhealed toxic reactions of ≥ grade 2 (CTCAE 5.0 standard) associated with any previous treatment, any level of hair loss, and platinum drugs Except for grade 2 neuropathy caused; 6. Patients with leptomeningeal metastasis, brainstem metastasis, or spinal cord compression; 7. Presence of dysphagia or gastrointestinal disorders that may interfere with oral medication absorption; 8. Previous history includes interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or evidence of clinically active ILD; 9. Have previously received hematopoietic stem cell transplants or solid organ transplants, or plan to receive hematopoietic stem cell transplants or solid organ transplants during the current period of study; 10. There are serious or active infections that required intravenous antibiotics or hospitalization, such as HBV (HBsAg-positive and peripheral HBV-DNA titer test≥1×104 copies/mL or 2000 IU/mL), HCV, HIV, and syphilis; 11. Serious or uncontrolled cardiovascular disease; 12. Pregnant or lactating females; 13. Other primary malignancies have been diagnosed within the last 5 years, and the following conditions can be enrolled: non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ that has undergone surgery and has been cured;

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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.

  1. The places running it

    1 site. 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

  • Shanghai East Hospital

    RECRUITING

    Shanghai, China

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