KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
Conditions
Brief summary
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
Interventions
DRUGHRS-7058
HRS-7058
DRUGFulzerasib Tablets
600mg BID
DRUGGarsorasib Tablets
600mg BID
DRUGGlecirasib Citrate Tablets
800mg QD
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 years old to 75 years old ( including both ends ), regardless of gender ; 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer ; 3. Histological specimens confirmed the presence of KRAS G12 C mutation ; 4. 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 ) ; 5. At least one measurable lesion conforming to the definition of RECIST v1.1 standard ; 6. ECOG physical score 0-1 points ; 7. Expected survival time ≥ 12 weeks ; 8. Have adequate bone marrow and organ function 9. Subjects were required to give informed consent to this study before the trial and voluntarily sign a written informed consent form.
Exclusion criteria
1. Subjects with active central nervous system ( CNS ) metastasis ; 2. 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. 3. Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug ; 4. 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 ; 5. Have serious cardiovascular and cerebrovascular diseases 6. Severe infection occurred within 4 weeks before the first administration. 7. The first study of arterial / venous thrombosis events within 3 months before medication was conducted. 8. Have a history of immunodeficiency, including HIV test positive ; 9. There is active hepatitis B or hepatitis C ; 10. Subjects with active central nervous system ( CNS ) metastasis ;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS based on BICR evaluation | about 32 months |
Secondary
| Measure | Time frame |
|---|---|
| OS | about 45 months |
| PFS based on researcher 's assessment | about 32 months |
| ORR based on researchers and BICR assessment | about 45 months |
| DoR based on researchers and BICR evaluation | about 45 months |
| DCR based on researcher and BICR assessment | about 45 months |
| The incidence and severity of adverse events ( AE ) | about 45 months |
| the occurrence of severe adverse events ( SAE ) | about 45months |
Countries
China
Contacts
CONTACTSida Zhu
CONTACTHan Xu
Outcome results
None listed