Primary Tumor Resection With Sintilimab and Chemotherapy in Advanced NSCLC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

October 1, 2028

Study Completion Date

October 1, 2030

Conditions
Non Small Cell Lung Cancer
Interventions
PROCEDURE

Cytoreductive surgery

* Preoperative evaluation must confirm resectability. Thoracoscopic minimally invasive surgery will be performed, with the surgical approach selected according to disease conditions, such as lobectomy, segmentectomy, wedge resection, or sleeve resection; ② Systematic mediastinal lymph node dissection or lymph node sampling (based on preoperative imaging and intraoperative evaluation) must be performed; ③ Postoperative recovery must be adequate (postoperative complications ≤ Clavien-Dindo grade II).

DRUG

Immunochemotherapy

"1. Treatment phase:~ ① Sintilimab Dose: 200 mg, administered intravenously over 30 minutes or less;~ ② Pemetrexed Dose: 500 mg/m², administered intravenously over 10 minutes or less;~ ③ Carboplatin Dose: administered according to the area under the curve (AUC) of 5 mg/mL/min, with infusion time controlled within 15-60 minutes.~ The above regimen will be administered every 3 weeks after surgery for a total of 4 cycles.~2. Maintenance phase:~ * Sintilimab Dose: 200 mg, administered intravenously over 30 minutes or less; ② Pemetrexed Dose: 500 mg/m², administered intravenously over 10 minutes or less; The above regimen will be administered every 3 weeks. Maintenance with sintilimab will continue for up to 31 cycles, or the total duration of systemic therapy from randomization will not exceed 2 years, or until disease progression or the occurrence of unacceptable toxicity"

All Listed Sponsors
lead

Jianxing He

OTHER