Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC
Trial Parameters
Brief Summary
Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Toripalimab plus chemotherapy in rare mutations stage IIB-IIIB NSCLC followed by optional adjuvant treatment upon investigators' decisions.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18 Years and older 2. ECOG physical score 0-1 points; expected survival time ≥ 3 months; 3. Pathologically confirmed diagnosis with Stage IIB-IIIB NSCLC which harbored rare driver alteration including RET fusions, BRAF (V600E or non-V600E but confirmed driver mutations), ERBB2 exon20 insertion, MET amplification (FISH confirmed) or exon 14 skipping. Suspected N2 disease should be confirmed by either mediastinoscopy or EBUS. N1 disease could be determined through PET/CT but biopsy of primary lung cancer is needed; 4. Lung function capacity capable of tolerating the proposed lung surgery 5. Available tissue of tumor for PD-L1 test 6. Subjects voluntarily joined the study and signed informed consent, with good compliance to follow-up. Exclusion Criteria: 1. Stage I and stage IV NSCLC; 2. Patients who have previously used any other anti-tumor drugs or radiotherapy; 3. Large panel NGS indicated sensitive EGFR alteration, ALK fusion, ROS1 fusion or any other drive