Clinical Trials /

A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC

NCT03856411

Description:

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).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate the Efficacy and Safety of JS001 or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: JS001-019-III-NSCLC
  • NCT ID: NCT03856411

Conditions

  • Treatment-naive Advanced Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapyGroup TORIPALIMAB combined with standard chemotherapy

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Group TORIPALIMAB combined with standard chemotherapyPlacebo Comparator
  • TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Group Placebo combined with standard chemotherapyPlacebo Comparator
  • TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Eligibility Criteria

        Inclusion Criteria:

        Only the patients meeting all the following criteria can be eligible to participate in the
        trial:

          1. Histologically and/or cytologically confirmed stage IV non-small cell lung cancer and
             ALK fusion

          2. At least one measurable lesion 3 No history of any systemic anti-tumor therapy.

        4. Agreement on providing formalin fixed tumor tissue specimen or fresh biopsy tissue from
        tumor lesions after diagnosis of metastasis 6. Age of 18-75 years 7. ECOG Scores 0-1; 8.
        Expected survival ≥ 3 months;

        Exclusion Criteria:

          1. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its
             components;

          2. Histologically or cytopathologically confirmed combination with small cell lung cancer
             component or sarcomatoid lesion;

          3. Current participation in and receiving other study treatment, or participation in
             treatment of one study drug within 4 weeks prior to administration of JS001;

          4. Previous use of systematic chemotherapy for advanced NSCLC; targeted therapy for
             advanced NSCLC

          5. 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);

          6. Chest (lung) radiotherapy > 30 Gy within 6 months prior to the start of study
             treatment.

          7. Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one
             year prior to screening;

          8. Known active central nervous system (CNS) metastasis and/or cancerous meningitis;

          9. 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

         10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated
             drainage

         11. Uncontrollable or symptomatic hypercalcemia

         12. Clinically uncontrolled active infection, including but not limited to acute
             pneumonia;

         13. Uncontrollable major epileptic seizure or superior vena cava syndrome

         14. Previous or current combination with other malignancies ;

         15. History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating
             bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active
             pneumonia during chest CT scanning for screening;

         16. Known hepatic diseases of clinical significance, including active viral hepatitis,
             alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver
             disease;

         17. Use of systemic immunosuppressive therapy for any active autoimmune disease within two
             years prior to Day 1 of the 1st cycle;

         18. Vaccination of live-virus vaccine within 30 days after the start of planned treatment
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:PFS
Time Frame:Up to 2 approximately years
Safety Issue:
Description:Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)

Secondary Outcome Measures

Measure:OS
Time Frame:Up to 2 approximately years
Safety Issue:
Description:Overall survival (OS)
Measure:PFS
Time Frame:Up to 2 approximately years
Safety Issue:
Description:PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria
Measure:ORR
Time Frame:Up to 2 approximately years
Safety Issue:
Description:Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1
Measure:DOR
Time Frame:Up to 2 approximately years
Safety Issue:
Description:Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1
Measure:DCR
Time Frame:Up to 2 approximately years
Safety Issue:
Description:Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1
Measure:TTR
Time Frame:Up to 2 approximately years
Safety Issue:
Description:Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1
Measure:Incidence of AEs/SAEs
Time Frame:From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Safety Issue:
Description:Overall incidence of adverse events (AEs); incidence of grade 3 and above AEs; incidence of serious adverse events (SAEs); incidence of AEs leading to termination of the investigational drug; incidence of AEs interruption of the investigational drug

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Shanghai Junshi Bioscience Co., Ltd.

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