Sintilimab Plus Chemotherapy as Induction Therapy for Unresectable Stage IIIC NSCLC

This is a prospective, single-center phase II study evaluating sintilimab plus chemotherapy as induction therapy for unresectable stage IIIC non-small cell lung cancer (NSCLC). Treatment-naive eligible patients who signed informed consent were enrolled after MDT screening. Patients received 4 cycles of sintilimab 200 mg intravenously every 3 weeks combined with chemotherapy. Post-treatment MDT evaluation was performed. Resectable patients underwent primary tumor resection and mediastinal lymph node dissection 4-6 weeks after the 4th cycle. Postoperative supraclavicular radiotherapy and guideline-recommended adjuvant therapy were determined by MDT and investigators. Unresectable patients received concurrent chemoradiotherapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Sintilimab plus platinum-doublet chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ling Cai; Phone Number: +8613602766093; Email: cailing@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Signed written informed consent prior to any study-related procedures. Age ≥18 and ≤75 years, male or female. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). At least one measurable lesion per RECIST 1.1. Treatment-naive, initially unresectable stage IIIC NSCLC (UICC/AJCC 9th edition).

No known EGFR/ALK sensitive mutations. Willing to undergo re-evaluation for surgery and accept surgery if eligible. No absolute contraindications to surgery. ECOG performance status 0-1. Life expectancy >6 months. Adequate organ function. Negative pregnancy test for fertile females.

Exclusion Criteria:

Other malignancy within 5 years (except cured basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ).

Participation in another interventional clinical study within 4 weeks. Prior anti-PD-1/PD-L1/PD-L2 or other immune checkpoint inhibitor therapy. Systemic anti-tumor Chinese patent medicine or immunomodulatory drugs within 2 weeks.

Active autoimmune disease requiring systemic therapy within 2 years. Systemic glucocorticoid or immunosuppressive therapy within 7 days. History of allogeneic organ transplant or hematopoietic stem cell transplant. Hypersensitivity to sintilimab or any excipient. Inadequate recovery from prior interventions (≥Grade 2). Known HIV infection. Untreated active HBV infection; active HCV infection. Live vaccine within 30 days. Pregnant or lactating women. Severe uncontrolled systemic disease (cardiac, pulmonary, hepatic, renal, infectious, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sintilimab combined with chemotherapy as induction therapy; Sintilimab 200 mg Q3W plus chemotherapy for 4 cycles as induction therapy for unresectable stage IIIC NSCLC. Resectable patients undergo surgery; unresectable patients receive concurrent chemoradiotherapy.	Drug: Sintilimab plus platinum-doublet chemotherapy; Sintilimab 200 mg intravenously every 3 weeks for 4 cycles combined with platinum-doublet chemotherapy (pemetrexed/paclitaxel/nab-paclitaxel plus carboplatin/cisplatin) as induction therapy. Resectable patients undergo surgery; unresectable patients receive concurrent chemoradiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical conversion rate	Up to 12 weeks after enrollment

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; sintilimab
• Other Study ID Numbers: 2025-FXY-345-放疗科

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No