Can a Two-Drug combo outsmart resistant lung cancer?
NCT ID NCT07109531
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 286 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- 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
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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: 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.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Shanghai East Hospital
RECRUITINGShanghai, China
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