Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Treatment-naive Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
- Uncontrollable or symptomatic hypercalcemia
- Clinically uncontrolled active infection, including but not limited to acute pneumonia;
- Uncontrollable major epileptic seizure or superior vena cava syndrome
- Previous or current combination with other malignancies ;
- 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;
- Known hepatic diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver disease;
- Use of systemic immunosuppressive therapy for any active autoimmune disease within two years prior to Day 1 of the 1st cycle;
- Vaccination of live-virus vaccine within 30 days after the start of planned treatment
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2023
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT03856411
Start Date
March 18 2019
End Date
January 9 2023
Last Update
February 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021