This study is a multicenter, prospective, open-label clinical trial. It enrolls previously untreated patients with resectable stage IB-IIIB KRAS G12C mutation-positive NSCLC to evaluate the efficacy and safety of glesorasib sequentially combined with ivonescimab and chemotherapy as perioperative treatment for this patient population.
Age Range: Males or females aged 18 years or older.
Diagnosis and Stage: Patients with histologically or cytologically confirmed resectable IB-IIIB NSCLC, staged according to the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, 9th Edition.
Informed Consent: Patients must voluntarily participate in the study, provide written informed consent, and be willing to comply with follow-up procedures.
Prior Therapy: No prior systemic therapy for locally advanced or metastatic NSCLC (including adjuvant chemo/radiotherapy, neoadjuvant chemo/radiotherapy, definitive chemoradiotherapy, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, or anti-angiogenic therapy for locally advanced disease).
Previous receipt of any anti-tumor therapy for lung cancer (including adjuvant chemoradiotherapy, neoadjuvant chemoradiotherapy, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, anti-angiogenic therapy, etc.).
Treatment with any other investigational drug within 28 days prior to the first dose in this study.
Treatment within 2 weeks prior to the first dose with NMPA-approved Chinese patent medicines explicitly indicated for anti-tumor purposes in their drug说明书 (e.g., Compound Banmao Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Yadanzi Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Huachansu Capsules, etc.).
Recent Surgery: Any surgery within 4 weeks prior to screening examinations.
Sequential
Garsorasib
DrugGarsorasib 600 mg, twice daily, for 4 to 6 weeks
Ivonescimab Combined With Chemotherapy
DrugAfter a 2-week washout period, administer Ivonescimab 20 mg/kg in combination with the PC regimen (paclitaxel 135-175 mg/m² + carboplatin AUC 5) every 3 weeks.
Surgery
Procedure/SurgerySurgery
Garsorasib
DrugIf MRD is positive and KRAS is positive, adjuvant therapy with Garsorasib 600 mg twice daily should be administered until disease progression, unacceptable toxicity, withdrawal of informed consent, death, or termination due to other reasons, whichever occurs first.
Ivonescimab
DrugIf MRD is positive and KRAS is negative, adjuvant therapy with Ivonescimab 20 mg/kg every 3 weeks should be administered until disease progression, unacceptable toxicity, withdrawal of informed consent, death, or termination due to other reasons, whichever occurs first.
Observation
BehavioralIf MRD is negative, the patient should be placed under observation; once it turns positive, they will enter the corresponding treatment group as described above.
Pathologic complete response (pCR) rate assessed according to the IASLC recommendations for pathologic evaluation of lung cancer neoadjuvant therapy
Major Pathological Response (MPR) rate assessed according to the IASLC recommendations for pathologic evaluation of lung cancer neoadjuvant therapy
R0 resection rate
Objective Response Rate (ORR)
One-year event-free survival rate (1-y EFS%)
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