Actively Recruiting
Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)
Led by Shanghai Chest Hospital · Updated on 2026-05-13
478
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of SBRT sequencial with Toripalimab and chemotherapy versus Toripalimab and chemotherapy for subjects with resectable, stage II-III NSCLC.
CONDITIONS
Official Title
Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- ECOG performance status score of 0 or 1
- Treatment-naive, histologically confirmed resectable stage II, IIIA, or IIIB (N2) NSCLC
- Measurable tumors according to standard evaluation criteria
- Available tumor tissue for pathological diagnosis and biomarker testing before randomization
- Lung function sufficient to tolerate pneumonectomy as judged by a doctor
- No EGFR or ALK sensitive gene mutations confirmed by molecular pathology
- Good organ function including bone marrow, liver, and kidney function within specified limits
- Ability to understand the study and willing to sign informed consent
- Negative pregnancy test for women of childbearing age within 3 days before first treatment
You will not qualify if you...
- Having unresectable or metastatic lung cancer
- NSCLC involving superior sulcus, large cell neuroendocrine carcinoma, or sarcomatoid tumor
- Known EGFR sensitive mutations or ALK translocation in non-squamous NSCLC
- Prior systemic antitumor treatment for early NSCLC
- History or ongoing pneumonitis or interstitial lung disease requiring steroids
- Active tuberculosis or infections needing systemic treatment
- Known or suspected autoimmune disorders or immunodeficiency except well-controlled hypothyroidism or type I diabetes
- Uncontrolled active hepatitis B or active hepatitis C infection
- Known HIV infection
- Live vaccination within 30 days before first dose
- Grade 2 or higher peripheral neuropathy
- Previous use of PD-1/PD-L1 agents or other targeted T cell receptor drugs
- Severe allergies to monoclonal antibodies or study drugs
- Serious or uncontrolled pre-existing diseases that may interfere with the study
- Other malignancies within 5 years except certain low-risk or treated cancers
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, China
Actively Recruiting
Research Team
X
Xuwei Cai
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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