ASKC202 with Limertinib combo vs platinum chemo after EGFR-TKI in MET-aligned NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label Phase 3 study comparing ASKC202 plus Limertinib against platinum-based chemotherapy in patients with MET-amplified/overexpressed NSCLC who progressed after EGFR-TKI treatment. Participants will receive treatment until disease progression, intolerable toxicity, withdrawal of consent, death, or other discontinuation reasons. The study will evaluate efficacy and safety of the combination therapy, with eligibility requiring measurable disease, good performance status, and adequate organ function. Interventions include ASKC202+Limertinib versus Pem/Gem or Cis/Carbo based on investigator choice. Enrollment targets adults (18+), with central confirmation of MET alterations and RECIST 1.1 measurable lesions.

Why it matters

Who can join: the full rules

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;

Where it's running

• Shanghai East Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jiangsu Aosaikang Study Director
• Email: ctr-contact@ask-pharm.com
• Phone: +86 025 52169999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Testing ASKC202 alone or with ASK120067 in adults with advanced solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.