Actively Recruiting
Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2026-02-13
54
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.
CONDITIONS
Official Title
Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is aged 18 years or older
- Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
- No prior anticancer therapy including chemotherapy, immunotherapy, or radiotherapy
- Investigator-assessed resectable stage II-IIIB NSCLC (excluding N3) per AJCC 9th edition
- Non-squamous NSCLC without EGFR mutation, ALK rearrangement, or other driver mutations with approved targeted agents
- Squamous NSCLC without known EGFR mutation, ALK rearrangement, or other actionable driver mutations
- Negative PD-L1 expression (22C3 or E1L3N assays)
- ECOG performance status of 0 or 1
- Adequate organ function within 7 days before first dose, including specific blood counts, liver and kidney function, coagulation, and pulmonary reserve
- Fertile females must have a negative serum pregnancy test within 7 days before first dose
- Fertile females and male patients with female partners of childbearing potential must use highly effective contraception from 7 days before first dose until 24 weeks after last dose
You will not qualify if you...
- Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery
- Systemic corticosteroid use (>10 mg/day prednisone or equivalent) or immunosuppressive agents for 7 or more consecutive days within 14 days before first dose, except for certain permitted uses
- Receipt of live vaccines within 28 days before first dose
- Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids
- Active autoimmune diseases or history of autoimmune disease except for stable hypothyroidism, type 1 diabetes, psoriasis, or vitiligo without systemic treatment
- Other malignancies within 5 years before first dose except those considered cured
- Uncontrolled comorbidities such as active hepatitis B or C, HIV/AIDS, active tuberculosis, active infections requiring prolonged antibiotics, significant cardiovascular disease, or abnormal urine protein levels
- History of allogeneic hematopoietic stem-cell or solid-organ transplantation
- Hypersensitivity to antibody therapies, history of anaphylaxis, uncontrolled asthma, or significant drug allergies
- Pregnancy or breastfeeding
- Other conditions affecting safety or treatment compliance, including psychiatric disorders and uncontrolled large serosal cavity effusions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
C
Chang Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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