Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Toripalimab combination with platinum-containing dual-drug chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toripalimab Combined With Platinum-containing Dual-agent<br>Toripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer | Drug: Toripalimab combination with platinum-containing dual-drug chemotherapy<br>* Nab-paclitaxel/pem +cisplatin +PD-1(Nab-paclitaxel260mg/m2 D1 Cisplatin 75mg/m2 D1 or carboplatin,determined by the investigator AUC)PD-1 200mg D1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 surgical resection rate | No residual ratio under the microscope after surgical resection | Approximately 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | To measure the patients's overall response rate | Approximately 1 years | 
| MPR | Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10% | Approximately 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toripalimab NSCLC