A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) or Placebo Combined With First-line Standard Chemotherapy in Treatment-naive Advanced Non-small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 3
- Intervention
- TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
- Conditions
- Treatment-naive Advanced Non-small Cell Lung Cancer
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 465
- Locations
- 1
- Primary Endpoint
- PFS
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is one randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo combined with standard 1st-line chemotherapy in treatment-naïve advanced non-small cell lung cancer (NSCLC); and evaluate the population with the best predictive biomarkers, i.e., positive diagnosis population.
About 450 subjects with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations) and ALK fusion will be 2:1 randomized into two groups, JS001 combined with the standard 1st-line chemotherapy will be given in the study group whereas placebo combined with standard 1st-line chemotherapy will be given in the control group. The stratification will be based on the following factors:
PD-L1 expression (TC≥1% vs TC<1%); Smoking state (often smoking vs no smoking or infrequent smoking); Pathological type (squamous cell carcinoma vs non-squamous cell carcinoma).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Only the patients meeting all the following criteria can be eligible to participate in the trial:
- •Histologically and/or cytologically confirmed stage IV non-small cell lung cancer and ALK fusion
- •At least one measurable lesion 3 No history of any systemic anti-tumor therapy.
- •Agreement on providing formalin fixed tumor tissue specimen or fresh biopsy tissue from tumor lesions after diagnosis of metastasis
- •Age of 18-75 years
- •ECOG Scores 0-1;
- •Expected survival ≥ 3 months;
Exclusion Criteria
- •Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components;
- •Histologically or cytopathologically confirmed combination with small cell lung cancer component or sarcomatoid lesion;
- •Current participation in and receiving other study treatment, or participation in treatment of one study drug within 4 weeks prior to administration of JS001;
- •Previous use of systematic chemotherapy for advanced NSCLC; targeted therapy for advanced NSCLC
- •Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cells synergetic stimulation or checkpoint pathway, such as IDO, IL-2R, GITR);
- •Chest (lung) radiotherapy \> 30 Gy within 6 months prior to the start of study treatment.
- •Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one year prior to screening;
- •Known active central nervous system (CNS) metastasis and/or cancerous meningitis;
- •Spinal cord compression for which operation and/or radical radiotherapy has not been given, or no clinical evidence of stable disease for ≥4 weeks prior to enrollment after treatment for previously diagnosed spinal cord compression
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
Arms & Interventions
Group TORIPALIMAB combined with standard chemotherapy
Intervention: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Group Placebo combined with standard chemotherapy
Intervention: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Outcomes
Primary Outcomes
PFS
Time Frame: Up to 2 approximately years
Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)
Secondary Outcomes
- ORR(Up to 2 approximately years)
- DCR(Up to 2 approximately years)
- TTR(Up to 2 approximately years)
- PFS(Up to 2 approximately years)
- DOR(Up to 2 approximately years)
- Incidence of AEs/SAEs(From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years)
- OS(Up to 2 approximately years)