Actively Recruiting
The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer
Led by Shanghai Chest Hospital · Updated on 2026-03-11
124
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
S
Shanghai Chest Hospital
Lead Sponsor
S
Shanghai Junshi Bioscience Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This randomized phase II trial is to explore the clinical efficacy, safety and feasibility of neoadjuvant immunotherapy plus radiotherapy compared with neoadjuvant immunotherapy plus chemotherapy in operable stage II-IIIA (N+) non small cell lung cancer (NSCLC) and the optimal radiotherapy pattern.
CONDITIONS
Official Title
The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- ECOG performance status of 0 or 1
- Pathologically confirmed non-small cell lung cancer
- Enough tumor tissue available for biomarker testing
- Clinical stage cT1-2N1-2M0 or T3N1M0, corresponding to stage II-IIIA
- No distant metastases confirmed by CT or PET/CT
- Physically able to undergo radical lung cancer surgery
- No classic driver mutations in EGFR, ALK, or ROS1 confirmed by histomolecular pathology
- Normal organ function as shown by laboratory tests within one week before enrollment, including:
- Adequate bone marrow function (ANC ≥ 1.5x10^9/L, platelets ≥ 100x10^9/L, hemoglobin ≥ 9g/dL)
- Liver function with bilirubin ≤ 1.5 times normal, ALT and AST ≤ 2.5 times normal
- Kidney function with creatinine ≤ 1.5 times normal or creatinine clearance ≥ 60 ml/min
- Urine protein less than +; if +, 24-hour protein must be less than 500 mg
- Blood glucose within normal range or stable in treated diabetic patients
- Pulmonary function with baseline FEV1 at least 2L or expected > 800 ml post-surgery
- Cardiac function without recent myocardial infarction, unstable angina, severe arrhythmia, or insufficiency
- Voluntary participation with signed informed consent
You will not qualify if you...
- Diagnosis of compound small cell lung cancer or similar pathology
- History of previous lobectomy, radiotherapy, or chemotherapy
- Concurrent second primary cancer or malignancy within past 5 years except certain cured skin or cervical cancers
- Active or history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, enterocolitis, hepatitis, vasculitis, myocarditis, nephritis, thyroid disorders)
- Active infection needing systemic treatment or history of active tuberculosis
- Known HIV infection or active chronic Hepatitis B or C or uncontrolled systemic infection requiring IV antibiotics
- Presence of other uncontrollable diseases not suitable for surgery
- Conditions judged by investigator to interfere with study results or increase treatment risk
- Prior interstitial lung disease, drug-induced lung disease, or active interstitial lung disease with idiopathic pulmonary fibrosis
- Uncontrolled pleural or pericardial effusion
- Unstable systemic diseases such as active infection, moderate/severe COPD, uncontrolled hypertension, unstable angina, recent heart failure or myocardial infarction, severe mental disorders requiring treatment, liver or kidney disease, or neuropsychiatric conditions like Alzheimer's
- History of immunodeficiency or organ transplantation
- Prior treatment with radiotherapy, anti-PD-1/PD-L1/PD-L2 drugs, CTLA-4/OX-40/CD137 inhibitors, investigational drugs within 4 weeks, or recent major surgery or severe trauma
- Concurrent participation in other interventional clinical trials except observational or follow-up studies
- Receipt of antineoplastic or live vaccines within 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
X
Xiaolong Fu, MD
CONTACT
W
Wen Feng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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