Sintilimab Plus Chemotherapy as Induction Therapy for Unresectable Stage IIIC NSCLC

NCT07603661 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025-FXY-345-放疗科
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

non-small cell lung cancer; surgery

Outcome Measures

Primary Outcomes (1)

• Surgical conversion rate

  Up to 12 weeks after enrollment

Study Arms (1)

Sintilimab combined with chemotherapy as induction therapy

EXPERIMENTAL

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

Interventions

Sintilimab plus platinum-doublet chemotherapy DRUG

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.

Sintilimab combined with chemotherapy as induction therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ling Cai

CONTACT

+8613602766093; cailing@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share