Prospective Phase II Trial of Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Tislelizumab Combined With Chemotherapy
- Conditions
- NSCLC, Stage IIIA
- Sponsor
- Sun Yat-sen University
- Enrollment
- 48
- Primary Endpoint
- Surgical conversion rate
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer.
Detailed Description
This study is a prospective, single-arm, single-center phase II clinical trial to investigate the efficacy and safety of neoadjuvant treatment with tirilizumab in combination with chemotherapy in patients with initially inoperable stage III/N2 non-small cell lung cancer. Patients with stage III/N2 non-small cell lung cancer that is initially inoperable and clearly staged and meets the enrollment criteria will receive 3 cycles of tirilizumab (200 mg) in combination with chemotherapy and will be evaluated by imaging of their tumor status. After MDT evaluation patients will either undergo surgery or be withdrawn from the study and receive a combination of radiotherapy and chemotherapy, with postoperative adjuvant therapy at the discretion of the physician. The primary endpoint of this study is the surgical conversion rate; secondary endpoints include MPR, pCR, safety, and EFS.
Investigators
Xue Hou
Professor of Medicine
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Patients with initially untreated, unresectable stage III NSCLC (according to the International Association for the Study of Lung Cancer IASLC 8th Thoracic Tumor Stage) with non-small cell lung cancer
- •All patients received baseline PET/CT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging
- •Cytology/histology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer
- •For non-squamous cell carcinoma patients, if EGFR/ALK mutation status is unknown, tissue samples should be provided for EGFR/ALK gene testing before enrollment; For patients with squamous cell carcinoma, if EGFR/ALK mutation status is unknown, testing is not required during screening
- •ECOG (Performance status, PS) score 0-1
- •Hematology testings meet the following requirements
- •neutrophil ≥1.5\*109/L
- •Platelets ≥100\*109/L
- •Hemoglobin \> 9.0 g/dL
- •Serum creatinine ≤1.5ULN or creatinine clearance (Ccr) ≥40mL/min
Exclusion Criteria
- Not provided
Arms & Interventions
Tislelizumab
Tislelizumab 200mg Q3W
Intervention: Tislelizumab Combined With Chemotherapy
Outcomes
Primary Outcomes
Surgical conversion rate
Time Frame: Within 4-6 weeks (+7 days) after the third cycle of Tislelizumab combined with chemotherapy
After 3 cycles of Tislelizumab combined with chemotherapy, the number of patients who underwent surgical resection/number of patients enrolled
Secondary Outcomes
- Major pathologic response(MPR)(Within one week after surgery)
- Pathologic Complete response（pCR）(Within one week after surgery)