Locally Advanced or Metastatic NSCLCPhase 3NCT07109531
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
A Phase 3 study testing ASKC202+ Limertinib and Pemetrexed + Cisplatin /Carboplatin in people with Locally Advanced or Metastatic NSCLC, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic NSCLC
- What is being tested?
- ASKC202+ Limertinib and Pemetrexed + Cisplatin /Carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- ECOG performance status 0 or 1;
- Expected survival >12 weeks;
- Adequate bone marrow reserve or organ function.
Who cannot join
- 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;
- Patients with leptomeningeal metastasis, brainstem metastasis, or spinal cord compression;
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- Presence of dysphagia or gastrointestinal disorders that may interfere with oral medication absorption;
- 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;
- 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;
- Serious or uncontrolled cardiovascular disease;
- Pregnant or lactating females;
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai
Caicun zhou, PHD, +86-21-65115006, caicunzhoudr@163.com
About this study
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.
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.
Read the detailed description
This is a randomized, controlled, open-label, multicenter, phase 3 clinical study to valuate the efficacy and safety of ASKC202 combined with Limertinib in locally advanced or metastatic NSCLC with MET amplification/overexpression after failure of EGFR inhibitor therapy. Participants will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
- Conditions
- Locally Advanced or Metastatic NSCLC
- Being tested
- ASKC202+ Limertinib, Pemetrexed + Cisplatin /Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKC202+ LimertinibDrug
ASKC202 orally once per day (QD) combined with Limertinib orally BID for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.
Pemetrexed + Cisplatin /CarboplatinDrug
The standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed on Day 1of 21 day cycles for 4~6 cycles (every 3 weeks).
| Study group | Role | What they receive |
|---|---|---|
| ASKC202 + Limertinib | Experimental | ASKC202+Limertinib Receives: Drug: ASKC202+ Limertinib |
| Pemetrexed + Cisplatin /Carboplatin | Active comparator | Pemetrexed+Cisplatin/Carboplatin Receives: Drug: Pemetrexed + Cisplatin /Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) by BIRC
Progression-free survival (PFS) using BIRC assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first).
Measured: 2 years
Secondary outcomes (6)
Progression-free survival (PFS) by investigator
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first).
Measured: 2 years
Overall Survival (OS)
The time from the date of randomization to the date of death .
Measured: 3 years
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) .
Measured: 2 years
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with complete response(CR), partial response(PR) and stable disease(SD).
Measured: 2 years
Duration of Response (DoR)
Duration of response was defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression or death.
Measured: 2 years
Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as recorded on the case report form NCI CTCAE v5.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start4 Aug 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, open-label, multicenter, phase 3 clinical study. The primary endpoint of this study is PFS as assessed by BIRC. patients with locally advanced or metastatic NSCLC with MET amplification/Overexpression after failure of EGFR inhibitor therapy are randomly assigned 1:1 stratified by MET amplification (MET GCN≥10 or MET GCN\<10 )and brain metastasis (YES or NO) and EGFR mutation type(L858R；Del19) to receive ASKC202+ Limertinib or platinum-based chemotherapy.
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109531
- Sponsor's protocol ID
- ASKC202-301
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07109531
- Acronym / sponsor ID
- ASKC202-301
- Conditions
- Locally Advanced or Metastatic NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, controlled, open-label, multicenter, phase 3 clinical study to valuate the efficacy and safety of ASKC202 combined with Limertinib in locally advanced or metastatic NSCLC with MET amplification/overexpression after failure of EGFR inhibitor therapy. Participants will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, open-label, multicenter, phase 3 clinical study. The primary endpoint of this study is PFS as assessed by BIRC. patients with locally advanced or metastatic NSCLC with MET amplification/Overexpression after failure of EGFR inhibitor therapy are randomly assigned 1:1 stratified by MET amplification (MET GCN≥10 or MET GCN<10 )and brain metastasis (YES or NO) and EGFR mutation type(L858R；Del19) to receive ASKC202+ Limertinib or platinum-based chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| ASKC202 + Limertinib | Experimental | Drug: ASKC202+ LimertinibASKC202+Limertinib |
| Pemetrexed + Cisplatin /Carboplatin | Active comparator | Drug: Pemetrexed + Cisplatin /CarboplatinPemetrexed+Cisplatin/Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASKC202+ LimertinibASKC202 orally once per day (QD) combined with Limertinib orally BID for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met. | Drug | ASKC202 + Limertinib |
| Pemetrexed + Cisplatin /CarboplatinThe standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed on Day 1of 21 day cycles for 4~6 cycles (every 3 weeks). | Drug | Pemetrexed + Cisplatin /Carboplatin |
Primary outcome
Progression-Free Survival (PFS) by BIRC
Time frame: 2 years
Progression-free survival (PFS) using BIRC assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first).
6 secondary outcomes
Progression-free survival (PFS) by investigator
Time frame: 2 years
Overall Survival (OS)
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Response (DoR)
Time frame: 2 years
Incidence and severity of treatment-emergent adverse events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASKC202+ Limertinib and Pemetrexed + Cisplatin /Carboplatin in people with Locally Advanced or Metastatic NSCLC, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiangsu Aosaikang Study Director (+86 025 52169999, ctr-contact@ask-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) by BIRC (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.