ASKC202 with limertinib tested against osimertinib as first treatment for lung cancer
Tests ASKC202 with limertinib in adults with advanced EGFR-mutated, MET-positive lung cancer.
Plain-language title generated from the registry record
Registry title: ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
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 advanced non-squamous lung cancer who have not had treatment for it before. Their tumour must carry an EGFR mutation and show MET protein overexpression.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Locally advanced or metastatic non-squamous non-small cell lung cancer, which cannot be removed by surgery or treated with radiotherapy to remove all of the disease. At least one measurable lesion is needed.
- Earlier treatment
- No earlier treatment for the advanced cancer. Earlier adjuvant or neo-adjuvant treatment, or full radiation or chemoradiation, is allowed if it ended at least 6 months before the cancer came back. No earlier EGFR inhibitor or c-MET inhibitor, with one exception for people whose disease came back 12 months or more after completed adjuvant therapy.
- Biomarker or test result
- EGFR sensitizing mutation (Ex19Del or L858R) and MET protein overexpression, confirmed by central laboratory testing of tumour tissue.
Main reasons for not taking part
- Other known cancer-driving gene changes
- Symptomatic or unstable brain metastases
- Leptomeningeal disease, brainstem metastases or spinal cord compression
- Another cancer before or at the same time as the lung cancer
- Cannot swallow oral medicine, or a gut condition that could affect absorption of the drug
Read by machine on 9 November 2026.
Where in China
- Shanghai East HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Trial code
- NCT07897188
- Record updated
- 27 October 2026
- Original description
To evaluate the efficacy and safety of ASKC202 combined with limertinib as the first-line treatment for locally advanced or metastatic NSCLCRead full original descriptionShow less
A Randomized, Controlled, Double-Blind, Multicenter, Phase 3 Clinical Study of ASKC202 Plus Limertinib Versus Osimertinib for First-Line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
To evaluate the efficacy and safety of ASKC202 combined with limertinib as the first-line treatment for locally advanced or metastatic NSCLC
Inclusion: Capable of giving signed informed consent; Male or female, at least 18 years of age at the time of ICF signing; Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, not amenable to curative surgery or radiotherapy; Patients must have untreated advanced NSCLC not amenable to curative surgery or radiotherapy. Prior adjuvant and neo-adjuvant therapies or definitive radiation/chemoradiation are permitted as long as treatment was completed at least 6 months prior to the development of recurrent disease; The tumor harbors EGFR sensitizing mutation (Ex19Del or L858R); MET protein overexpression as determined by central laboratory testing of tumor tissue samples; At least one measurable lesion as assessed by RECIST v1.1; Have adequate organ functions; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Have an estimated life expectancy ≥ 12 weeks.
Exclusion: Receipt of any other investigational agent within 4 weeks prior to the first dose of study treatment; Unresolved toxicity of CTCAE Grade ≥2 severity attributed to prior anti-tumor therapy at the time of first dose of study drug; Prior or concurrent malignancy other than study disease; Presence of leptomeningeal disease, brainstem metastases, or spinal cord compression; Inability to swallow oral medication, or any gastrointestinal disease or condition that may significantly impair the absorption of the study drug; Any other serious or uncontrolled acute or chronic medical condition that, in the investigator's judgment, would render the patient unsuitable for participation in the study; Prior therapy with an EGFR inhibitor (Patients who have completed the maximum permitted duration of adjuvant therapy and whose disease progressed or recurred ≥12 months after completion of such therapy are eligible for enrollment) or a c-MET-targeted inhibitor; Known coexistence of other oncogenic driver gene alterations; Patients with symptomatic brain metastases or unstable brain metastases.