NCT06962189

The Efficacy and Safety of Sintilimab Plus Chemotherapy in Surgical Conversion for Patients With Unresectable Stage IIIB-IIIC NSCLC: A Prospective, Single-Arm, Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the conversion rate to curative-intent treatment in patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) following induction therapy with PD-1 blockade combined with chemotherapy, and to assess progression-free survival (PFS) in these patients who underwent curative-intent treatment .

Detailed description

This study is a prospective phase II trial designed to evaluate the safety and efficacy of radical resection of the primary lung lesion combined with radical radiotherapy for metastatic lymph nodes, followed by sequential PD-1 inhibitor consolidation therapy, in treatment-naïve patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) who received induction therapy with Sintilimab plus platinum-based doublet chemotherapy. The study plans to enroll 39 pathologically confirmed, driver mutation-negative, treatment-naïve stage IIIB-IIIC NSCLC patients. Eligible patients will receive 3-4 cycles of Sintilimab combined with platinum-based doublet induction chemotherapy, followed by assessment for feasibility of radical lung resection.The primary objectives are to evaluate: (1)The conversion rate to curative-intent treatment (radical resection and/or definitive radiotherapy) after induction chemoimmunotherapy in treatment-naïve unresectable stage IIIB-IIIC NSCLC patients; (2) Progression-free survival (PFS) in patients who undergo curative-intent treatment post-induction. Secondary objectives include observation of adverse event rates, objective response rate (ORR), major pathological response (MPR), PFS, overall survival (OS), and exploration of biomarkers associated with treatment efficacy and prognosis.

Conditions

• Non Small Cell Lung Cancer (Stage III)

Interventions

Type	Name	Description
DRUG	chemoimmunothrapy	Patients will receive 3-4 cycles of induction therapy with Sintilimab combined with platinum-based doublet chemotherapy, followed by multidisciplinary team (MDT) evaluation. For patients deemed eligible for radical lung primary lesion resection, surgery should be performed within 4-6 weeks after completing the final cycle of chemoimmunotherapy. The timing of radiotherapy for metastatic lymph nodes will be determined by MDT discussion. If deemed inoperable after induction therapy by MDT, definitive radiotherapy will be administered subsequently. All patients, in the absence of contraindications, will receive PD-1 inhibitor maintenance therapy for 1 year following local treatment.

Timeline

• Start date: 2025-05-15
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-05-08
• Last updated: 2025-05-08