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).
Title
- Brief Title: A Study to Evaluate the Efficacy and Safety of Toripalimab 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
Drug | Synonyms | Arms |
---|
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy | JS001, TAB001 | Group Placebo 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
Name | Type | Description | Interventions |
---|
Group TORIPALIMAB combined with standard chemotherapy | Experimental | | - TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
|
Group Placebo combined with standard chemotherapy | Placebo 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: | Recruiting |
Lead Sponsor: | Shanghai Junshi Bioscience Co., Ltd. |
Last Updated
September 30, 2020