Clinical trial · Interventional
Sintilimab Plus Chemotherapy as Induction Therapy for Unresectable Stage IIIC NSCLC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab plus platinum-doublet chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sintilimab combined with chemotherapy as induction therapy
- description
- 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.
- interventionNames
- Drug: Sintilimab plus platinum-doublet chemotherapy
Primary outcomes (1)
- measure
- Surgical conversion rate
- timeFrame
- Up to 12 weeks after enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available