A Phase II Study on Toripalimab Combined With Double Platinum Based Chemotherapy for as a Neoadjuvant Therapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

TOGATHER

The aim of the study was to investigate the safety and efficacy of Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer.

2019-01-16

2022-06-30

2023-07-30

Completed

Early phase I

40

Inclusion Criteria: 1. Previously untreated, histologically confirmed potentially resectable stage IIIA or IIIB (AJCC staging eighth edition) NSCLC; potentially resectable refers to a discussion by the surgeon, including primary T3 or T4, mediastinum Lymph node metastasis (N2) is defined as: single-site or multi-station metastasis can be confirmed by imaging or pathology with a short diameter ≥ 2 cm, and it is expected that resection is difficult or pneumonectomy is required; 2. Before the enrollment, submit the PD-L1 immunohistochemistry section and the corresponding pathology report for biomarker evaluation (the tumor tissue sample must be fresh or archived samples obtained within 3 months before enrollment; Fresh tissue must be a needle biopsy, excision or incision biopsy specimen); Exclusion Criteria: Patients received Toripalimab before Patients with contraindication of chemotherapy Pregnant or breast feeding women

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2023-08-15