Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC (NCT07294261) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC
China69 participantsStarted 2025-12-23
Plain-language summary
This study is aimed to evaluate the efficacy and safety of the Garsorasib combination therapy in KRAS G12C mutant locally advanced and metastatic NSCLC
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 1\. A written informed consent form should be signed prior to any study-related procedures 2. Male or female, aged 18 or above. 3.Histologically confirmed IIIB-IV NSCLC. 4.Subjects have not received systemic treatment for locally advanced or metastatic non-small cell lung cancer. 5.The patients should be confirmed with KRAS G12C mutation and provide PD-L1 test result. 6.At least 1 measurable lesion (RECIST 1.1 criteria). 7.ECOG 0-1. 8. Good organ function includes:
* Neutrophil count≥1.5×109/L,
* Platelet count≥90×109/L,
* Hemoglobin≥90g/L
* Serum creatinine≤1.5×upper limit of normal (ULN), creatinine clearance≥50 mL/min (Cockcroft-Gault formula)
* Total bilirubin≤1.5×ULN
* AST and ALT≤2.5×ULN; for patients with liver metastasis, AST and ALT≤5×ULN, the investigator should determine whether they are enrolled
* Normal coagulation function: INR and PT≤1.5×ULN ,APTT≤1.5×ULN
* Urinary protein in routine urinalysis is less than 2+, or 24-hour urinary protein quantification is \< 1 g.
9\. Life expectancy is at least 3 months; 10.Negative pregnancy test at enrollment. Male or female subjects should commit to take adequate and effective contraceptive measures or abstain from sexual for the duration of study participation and within 3 months after the last dose of the study drug
Exclusion Criteria:
* 1.Patients received anti-tumor drug treatment or investigational drug treatment 3 years ago.2.Non-Small Cell Lung Cancer (NSCLC) with a history of other actiona…