non-small cell lung cancer
Conditions
Interventions
Test group:Garsorasib
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects are able to understand the informed consent form, voluntarily participate, and sign the informed consent form. 2. Subjects are >=18 years old, with no gender restriction. 3. Subjects have recovered from surgery (or chemotherapy), with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Pathologically confirmed Stage IB-IIIB (excluding N3) NSCLC (AJCC 9th edition) after complete resection. 5. Subjects must have undergone complete resection of NSCLC (no residual tumor and all surgical margins negative); resection methods include: lobectomy, sleeve lobectomy, bilobectomy, segmentectomy (to be assessed by the investigator as complete resection), or pneumonectomy; and systematic mediastinal lymph node dissection or lobe-specific mediastinal lymph node dissection must have been performed. 6. Tumor tissue sample confirmed to have a KRAS G12C mutation (detection methods include PCR, NGS); immunohistochemistry indicates PD-L1 expression less than 50% (22C3 or E1L3N). 7. Head imaging (preferably enhanced cranial MRI) is required pre-surgery or pre-enrollment. 8. Whether to administer postoperative adjuvant chemotherapy will be discussed and decided by the investigator or attending physician. Enrollment must be completed within 12 weeks or 28 weeks after surgery, depending on whether adjuvant chemotherapy was given. The regimen should be platinum-based and no more than 4 cycles. 9. Organ function must meet the following criteria within 10 days before the first dose: * Bone marrow function: * Hemoglobin >= 90 g/L; * Absolute neutrophil count >= 1.5 x 10^9/L; * Platelet count >= 100 x 10^9/L; * Renal function: * Serum creatinine <= 1.5 x ULN [Upper Limit of Normal] * Liver function: * Transaminases (ALT and AST) <= 3 x ULN; 10. Women of childbearing age should take appropriate contraceptive measures and should not breastfeed for 3 months after screening and discontinuing study treatment. Before starting the medication, the pregnancy test was negative. 11. Male patients should use barrier contraception (i.e. condoms) from screening to 3 months after discontinuing study treatment.
Exclusion criteria
Exclusion criteria: 1. Subjects who have only undergone wedge resection. 2. Received neoadjuvant therapy prior to surgery. 3. Received other targeted therapy or immunotherapy after surgery. 4. Concurrent malignant tumors requiring active and continuous anti-tumor treatment within 5 years prior to the first dose, excluding tumors assessed by the investigator as cured. 5. Intractable nausea, vomiting, or chronic gastrointestinal disease, inability to swallow the study drug, or history of extensive bowel resection that may affect adequate drug absorption. 6. Any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, or active hepatitis, HIV, etc., unless the investigator deems it will not affect the subject's safety or adherence to the study protocol. 7. History of allogeneic bone marrow or organ transplantation. 8. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease. 9. Pregnant and/or breastfeeding women. 10. Patients who, in the investigator's judgment, may have poor adherence to the study procedures and requirements, such as patients with psychiatric disorders. 11. Patients with any condition that, in the investigator's judgment, may jeopardize patient safety or interfere with study assessments. 12. History of hypersensitivity reaction to any active or inactive ingredient of the drug, or to drugs with similar chemical structures or in the same class as the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year DFS rate;Disease free survival;safety; | — |
Countries
China
Contacts
Public ContactDong Xie
Shanghai Pulmonary Hospital
Outcome results
None listed