About this trial
The study is being conducted to evaluate the efficacy, and safety of HRS-7058 in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years old to 75 years old ( including both ends ), regardless of gender ;
Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer ;
Histological specimens confirmed the presence of KRAS G12 C mutation ;
Participants who have failed at least one line of systemic anti-tumor treatment in the locally advanced or metastatic stage. Previous systemic anti-tumor treatment should include : platinum-containing double-agent chemotherapy and immune checkpoint inhibitor therapy ( synchronous or sequential, except that the researchers determine that it is not suitable for immune checkpoint inhibitors or chemotherapy ) ;
Disqualifiers
Subjects with active central nervous system ( CNS ) metastasis ;
Other malignant tumors occurred within 5 years before the first administration, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection.
Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug ;
Subjects with a history of interstitial pneumonia or suspected interstitial pneumonia by imaging examination during screening ; or other lung diseases that seriously affect lung function ;
Trial design
Parallel
Treatments tested in this trial
HRS-7058
DrugHRS-7058
Fulzerasib Tablets
Drug600mg BID
Garsorasib Tablets
Drug600mg BID
Glecirasib Citrate Tablets
Drug800mg QD
Treatment groups
Trial outcomes
Primary outcomes
PFS based on BICR evaluation
Secondary outcomes
OS
PFS based on researcher 's assessment
ORR based on researchers and BICR assessment
DoR based on researchers and BICR evaluation
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: