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CompletedNCT03856411Updated Feb 1, 2023

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

A Phase 3 interventional study of TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy in Treatment-naive Advanced Non-small Cell Lung Cancer, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
465
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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).

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Conditions studied

  • Treatment-naive Advanced Non-small Cell Lung Cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 465 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 98 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
  1. 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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
465 participants (actual)

Study arms

  • Experimental
    Group TORIPALIMAB combined with standard chemotherapy

    Drug: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy

  • Placebo comparator
    Group Placebo combined with standard chemotherapy

    Drug: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy

Interventions

  • DrugTORIPALIMAB INJECTION (JS001 ) combine with chemotherapy

    TORIPALIMAB INJECTION(JS001 ) or Placebo ,240mg/6ml/vial, Q3W,up to 2 years of treatment.

    Also known as: JS001, TAB001

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What researchers measure

Primary outcomes

  1. PFS

    Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)

    Time frame: Up to 2 approximately years

Secondary outcomes

  1. OS

    Overall survival (OS)

    Time frame: Up to 2 approximately years

  2. PFS

    PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria

    Time frame: Up to 2 approximately years

  3. ORR

    Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1

    Time frame: Up to 2 approximately years

  4. DOR

    Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1

    Time frame: Up to 2 approximately years

  5. DCR

    Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1

    Time frame: Up to 2 approximately years

  6. TTR

    Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1

    Time frame: Up to 2 approximately years

  7. Incidence of AEs/SAEs

    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

    Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

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Study locations

1 site
  • Cancer Hospital Chinese Academy of Medical Sciences
    Beijing, Beijing 100021, China
08

References and documents

Publications

  • Wang Z, Wu L, Li B, Cheng Y, Li X, Wang X, Han L, Wu X, Fan Y, Yu Y, Lv D, Shi J, Huang J, Zhou S, Han B, Sun G, Guo Q, Ji Y, Zhu X, Hu S, Zhang W, Wang Q, Jia Y, Wang Z, Song Y, Wu J, Shi M, Li X, Han Z, Liu Y, Yu Z, Liu AW, Wang X, Zhou C, Zhong D, Miao L, Zhang Z, Zhao H, Yang J, Wang D, Wang Y, Li Q, Zhang X, Ji M, Yang Z, Cui J, Gao B, Wang B, Liu H, Nie L, He M, Jin S, Gu W, Shu Y, Zhou T, Feng J, Yang X, Huang C, Zhu B, Yao Y, Tang X, Yu J, Maher E, Feng H, Yao S, Keegan P, Wang J. Toripalimab Plus Chemotherapy for Patients With Treatment-Naive Advanced Non-Small-Cell Lung Cancer: A Multicenter Randomized Phase III Trial (CHOICE-01). J Clin Oncol. 2023 Jan 20;41(3):651-663. doi: 10.1200/JCO.22.00727. Epub 2022 Oct 7. PubMed 36206498 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03856411
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Responsible party
Sponsor
First posted
Feb 27, 2019
Start date
Mar 18, 2019
Primary completion
Aug 31, 2022
Completion
Jan 9, 2023
Last update
Feb 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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