A Phase 3 interventional study of ASKC202 and ASKC202 placebo in EGFR Activating Mutation, Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and MET Positive, sponsored by Jiangsu Aosaikang Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Jiangsu Aosaikang Pharmaceutical Co., Ltd. (part of Beijing Aosaikang Pharmaceutical Co., Ltd.) · Phase 3, Interventional, and Treatment
Among 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China — 764 open to participants now, 986 under way, 202 of them phase 3. Carcinoma, Non-Small-Cell Lung · China.
Among the 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China, this one is the 262nd largest by planned enrollment of the 1,591 interventional ones, is one of 187 that started in 2026, is one of 365 in phase 3, reaches primary completion later than 958 of the 985 other live ones, and was the 1,875th registered.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 425 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →764 of the 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,877 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 187 started in 2026.
Median enrollment 100 across the 1,591 interventional studies, 200 across the 286 observational. Of the 452 that completed or were terminated, 130 (29%) have results posted.
803 of 1,877 have an industry lead sponsor. The 10 most frequent:
Jiangsu Aosaikang Pharmaceutical Co., Ltd. is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Jiangsu Aosaikang Pharmaceutical Co., Ltd. has 6 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
228 of the studies in Carcinoma, Non-Small-Cell Lung with a site in China that are under way reach primary completion within a year, 33 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06448312Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2026-11 |
| NCT06704620Phase 3Tianjin Medical University Cancer Institute and HospitalStudy of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer | 2026-11 |
| NCT05429463Phase 3Second Affiliated Hospital, Zhejiang University, School of MedicineNeoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ） | 2026-11-30 |
| NCT06711900Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer | 2026-12 |
| NCT06382129Phase 3Sichuan Baili Pharmaceutical Co., Ltd.A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02) | 2026-12 |
Among the 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China, from their registry updates:
To evaluate the efficacy and safety of ASKC202 combined with limertinib as the first-line treatment for locally advanced or metastatic NSCLC
This is a randomized, controlled, multicenter, Phase 3 clinical study designed to evaluate the efficacy and safety of ASKC202 plus limertinib (double-blind Arm A) versus osimertinib (double-blind Arm B) as first-line treatment for patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR sensitizing mutations (19Del or 21 L858R) and MET protein overexpression. In addition, Arm C (open-label) will concurrently evaluate the efficacy and safety of osimertinib plus pemetrexed and cisplatin or carboplatin as first-line treatment for patients with EGFRm+/MET+ locally advanced or metastatic non-squamous NSCLC.
Eligible participants will be stratified by EGFR mutation status (19Del vs. L858R) and brain metastasis (yes vs. no) and randomly assigned in a 2:2:1 ratio to Arm A, Arm B, or Arm C. Participants in each arm will receive the corresponding study treatment (21-day cycle) until disease progression, death, intolerable toxicity, or fulfillment of any other protocol-defined treatment discontinuation criterion, whichever occurs first.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASKC202 tablets 200 mg once daily (QD) + limertinib tablets 80 mg twice daily (BID) + osimertinib placebo tablets QD, orally
Drug: ASKC202 · Drug: osimertinib placebo · Drug: Limertinib
Arm B: ASKC202 placebo tablets QD + limertinib placebo tablets BID + osimertinib tablets 80 mg QD, orally
Drug: ASKC202 placebo · Drug: osimertinib · Drug: limertinib placebo
Arm C: Osimertinib tablets 80 mg QD orally + pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin (AUC 5) by intravenous infusion on Day 1 of each 21-day cycle for up to 4 cycles; followed by maintenance therapy with osimertinib tablets 80 mg QD orally + pemetrexed 500 mg/m² by intravenous infusion on Day 1 of each 21-day cycle.
Drug: osimertinib · Drug: pemetrexed · Drug: cisplatin or carboplatin
ASKC202 tablets 200 mg QD
ASKC202 placebo tablets QD
osimertinib placebo tablets QD
osimertinib tablets 80 mg QD
pemetrexed 500 mg/m² by intravenous infusion on Day 1 of each 21-day cycle
Drug pages: Cisplatin · Carboplatin
cisplatin 75 mg/m² or carboplatin (AUC 5) by intravenous infusion on Day 1 of each 21-day cycle for up to 4 cycles
limertinib tablets 80 mg BID
limertinib placebo tablets BID
Progression-Free Survival (PFS) by BICR
Progression-free survival (PFS) using BICR 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 (whichever occurred first).
Time frame: 3 years
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 (whichever occurred first).
Time frame: 3 years
Overall Survival (OS)
The time from the date of randomization to the date of death.
Time frame: 4 years
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR).
Time frame: 3 years
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with complete response(CR), partial response(PR) and stable disease(SD).
Time frame: 3 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.
Time frame: 3 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 v6.0.
Time frame: 3 years
Start is estimated for Oct 2026; primary completion for Dec 2030, 50 months later.
Of 314 industry-sponsored phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's planned 50 months is above that.
Counting every sponsor, half of 423 studies reached it within 45 months; a quarter within 30 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ASKC202
Carcinoma, Non-Small-Cell Lung →
Jiangsu Aosaikang Pharmaceutical Co., Ltd. →