Actively Recruiting
Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
Led by Shanghai Chest Hospital · Updated on 2025-05-18
32
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy.
CONDITIONS
Official Title
Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and comply with study requirements
- Male or female aged 18 years or older
- Histologically or cytologically confirmed stage II-IIIB (N2) nonsquamous non-small cell lung cancer
- Known KRAS gene mutation
- Evaluated as eligible for complete surgical removal of tumor (R0 resection) before enrollment
- At least one measurable lesion by RECIST v1.1
- Eligible for platinum-based doublet chemotherapy
- ECOG performance status score of 0 or 1
- Adequate organ function during screening
- Good cardiopulmonary function suitable for surgery
- Patients of childbearing potential must use effective contraception during study and for 120 days after last dose
You will not qualify if you...
- Previous treatment for current lung cancer, including radiotherapy, chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy
- Locally advanced, unresectable disease
- Use of systemic immunomodulatory agents within 4 weeks before first dose
- Use of herbal medicine for cancer control within 14 days before first dose
- Receipt of live or attenuated vaccines within 4 weeks before enrollment or planned during study or within 5 months after last dose
- Systemic corticosteroid therapy above prednisone 10 mg/day or other immunosuppressive therapy within 14 days before first dose
- Active autoimmune disease requiring systemic treatment
- Interstitial lung disease, non-infectious pneumonitis, or uncontrolled diseases affecting study treatment
- History of major diseases affecting organ function
- Severe chronic or active infections requiring systemic treatment within 14 days before first dose
- Known HIV infection
- Previous allogeneic stem cell or organ transplantation
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
Actively Recruiting
Research Team
F
Feng Yao
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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