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Taking people in ChinaPhase 3

Tests ASKC202 with limertinib in lung cancer after EGFR drug failure

Tests ASKC202 with limertinib against chemotherapy in adults with lung cancer.

Key facts

Who runs it
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Where
Shanghai, ChinaSee the site
Trial code
Registry title
ASKC202 Combined With Limertinib Versus Platinum-based Chemotherapy in Treatment of Locally Advanced or Metastatic NSCLC With MET Amplification/Overexpression After Failure of EGFR-TKI Therapy
Status
Recruiting
Phase
Phase 3
People taking part
286 people, planned
Started
4 Aug 2025
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ASKC202+ Limertinib
  • Pemetrexed + Cisplatin /Carboplatin
Record updated
19 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with non-small cell lung cancer (NSCLC) that is locally advanced or has spread, and that has an EGFR mutation with MET amplification or overexpression. Their cancer must have grown after EGFR-TKI treatment. The trial compares ASKC202 plus Limertinib with platinum-based chemotherapy.

Age
18 years and older.
Sex
All sexes can join.
Disease stage
Locally advanced or metastatic non-small cell lung cancer (NSCLC). At least one tumour must be measurable on scans (RECIST criteria). People must be fully active or only mildly limited in daily life (ECOG 0 or 1). Expected survival must be more than 12 weeks. Bone marrow and organs must work well enough.
Earlier treatment
The cancer must have grown after earlier EGFR-TKI treatment. People who had or now have any treatment aimed at c-Met cannot join. People who already had systemic chemotherapy cannot join.
Biomarker or test result
EGFR mutation together with MET amplification or overexpression, confirmed by a central laboratory.

Main reasons for not taking part

  • Cancer spread to the lining of the brain and spinal cord (leptomeningeal), to the brainstem, or pressing on the spinal cord.
  • Past interstitial lung disease, drug-caused lung disease, radiation lung inflammation needing steroids, or active interstitial lung disease.
  • Serious or active infections needing antibiotics through a vein or hospital stay, such as HBV, HCV, HIV or syphilis.
  • Serious or uncontrolled heart or blood vessel disease, or a past or planned stem cell or organ transplant.
  • Being pregnant or breastfeeding, or another cancer in the last 5 years, with some exceptions.

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Willing and able to provide signed and dated informed consent
  • Patients at least 18 years of age
  • Locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • Objective disease progression following prior EGFR-TKI therapy
  • EGFR mutation with MET amplification/Overexpression by a central laboratory
  • Measurable lesions based on RECIST 1. 1
  • ECOG performance status 0 or 1
  • Expected survival >12 weeks
  • Adequate bone marrow reserve or organ function

Who cannot take part

  • Prior or ongoing treatment with any c-Met target
  • Previously received systemic chemotherapy
  • Patients requiring continuous use of systemic immunosuppressants or systemic corticosteroids within 2 weeks prior to the first dose
  • 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
  • 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
  • Previous history includes interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or evidence of clinically active ILD；
  • 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
  • Presence of dysphagia or gastrointestinal disorders that may interfere with oral medication absorption
  • Serious or uncontrolled cardiovascular disease
  • 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
  • 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
  • Patients with leptomeningeal metastasis, brainstem metastasis, or spinal cord compression
  • Pregnant or lactating females

Where in China

  • Shanghai East HospitalShanghai, ChinaContact: Caicun zhou, PHDTaking people

About the trial

What the trial wants to find out

This study is designed to compare the safety and efficacy of ASKC202 combined with Limertinib Versus platinum-based chemotherapy in locally advanced or metastatic NSCLC With MET Amplification/Overexpression after disease progression on EGFR tyrosine kinase inhibitor.

The 2 groups in the trial

  • ASKC202 + LimertinibTreatment being tested
  • Pemetrexed + Cisplatin /CarboplatinExisting treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of ASKC202 in Combination With Limertinib Versus Platinum-based Chemotherapy in Participants With MET Amplification/Overexpression Locally Advanced or Metastatic NSCLC Who Have Failed After Prior EGFR-TKI Therapy.
Plain-language title
Tests ASKC202 with limertinib in lung cancer after EGFR drug failureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 August 2026