Actively Recruiting
A Prospective, Single-arm Phase II Study of Tislelizumab with Chemotherapy Perioperative Treatment 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pathological complete response in adults with resectable stage II to IIIB (N2) KRAS-mutated nonsquamous non-small cell lung cancer. This Phase II study aims to assess the effectiveness and safety of combining tislelizumab with platinum-based doublet chemotherapy before surgery. The study focuses on participants who have not received prior lung cancer treatment and are eligible for curative surgical resection. Participants will receive tislelizumab administered by intravenous injection combined with platinum-based chemotherapy drugs such as cisplatin, carboplatin, or pemetrexed disodium, all given through IV infusion. The treatment is given in the perioperative period, meaning around the time of surgery, to evaluate its impact on tumor response and safety. The study follows a single-arm design, assessing the combination treatment's effects without comparison to other treatments. Throughout the study, participants will be monitored for pathological complete response up to three months after completing neoadjuvant treatment. Additional outcomes include major pathological response, objective response rate, event-free survival, overall survival, and treatment-related side effects over up to three years. Participants will undergo medical assessments, imaging to measure lesions, organ function tests, and safety evaluations. The total duration of follow-up extends to three years to observe long-term treatment effects and survival outcomes.
CONDITIONS
Brief 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
- Eligible for curative R0 surgical resection
- 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
- Good cardiopulmonary function suitable for surgery
- Willingness to use effective contraception during study and for 120 days after last dose if of childbearing potential
You will not qualify if you...
- Previous treatment for current lung cancer, including radiotherapy, chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy
- Presence of 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 5 months after last dose
- Use of systemic corticosteroids or immunosuppressive therapy within 14 days before first dose
- Active autoimmune disease requiring systemic treatment
- Interstitial lung disease, non-infectious pneumonitis, or uncontrolled other diseases
- History of major diseases affecting organ function
- Severe 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 3 months
Participants receive Tislelizumab combined with platinum doublet chemotherapy before surgery.
Multiple visits for chemotherapy and Tislelizumab infusions during the treatment period
Duration - 1 day
Participants undergo curative R0 surgical resection of the lung cancer.
1 visit (in-person) for surgery
Duration - Up to 3 years
Participants are monitored for response and adverse events for up to 3 years after treatment.
Periodic visits over 3 years for survival and safety assessments
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
F
Feng Yao
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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