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Treatment-naive Advanced Non-small Cell Lung CancerPhase 3NCT03856411

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

A Phase 3 study testing TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy in people with Treatment-naive Advanced Non-small Cell Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
465 participants
Where
1 siteChina
Study dates
18 Mar 2019to 9 Jan 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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.
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

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)

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).

Being tested
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TORIPALIMAB INJECTION (JS001 ) combine with chemotherapyDrug

    Also called JS001, TAB001

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

Study groups in NCT03856411
Study groupRoleWhat they receive
Group TORIPALIMAB combined with standard chemotherapyExperimentalNot described
Receives: Drug: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Group Placebo combined with standard chemotherapyPlacebo comparatorNot described
Receives: Drug: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

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

    Measured: Up to 2 approximately years

Secondary outcomes (7)

  1. OS

    Overall survival (OS)

    Measured: Up to 2 approximately years

  2. PFS

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

    Measured: Up to 2 approximately years

  3. ORR

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

    Measured: Up to 2 approximately years

  4. DOR

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

    Measured: Up to 2 approximately years

  5. DCR

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

    Measured: Up to 2 approximately years

  6. TTR

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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2019
  2. Study start18 Mar 2019
  3. Primary completion31 Aug 2022
  4. Study completion9 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
465 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03856411
Sponsor's protocol ID
JS001-019-III-NSCLC
Status last verified
Jan 2023
First submitted
24 Jan 2019
Last updated
1 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhong J, Fei K, Wu L, Li B, Wang Z, 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, Yao S, Yu J, Cai SL, Cai Y, Xu J, Zhuang W, Luo X, Duan J, Wang J. Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial. Signal Transduct Target Ther. 2024 Dec 24;9(1):369. doi: 10.1038/s41392-024-02087-6.

    PubMed 39715755

  • Zhao J, Wang L, Zhou A, Wen S, Fang W, Zhang L, Duan J, Bai H, Zhong J, Wan R, Sun B, Zhuang W, Lin Y, He D, Cui L, Wang Z, Wang J. Decision model for durable clinical benefit from front- or late-line immunotherapy alone or with chemotherapy in non-small cell lung cancer. Med. 2024 Aug 9;5(8):981-997.e4. doi: 10.1016/j.medj.2024.04.011. Epub 2024 May 22.

    PubMed 38781965

  • Zhang M, Xu K, Lin Y, Zhou C, Bao Y, Zhang L, Li X. Cost-effectiveness analysis of toripalimab plus chemotherapy versus chemotherapy alone for advanced non-small cell lung cancer in China. Front Immunol. 2023 May 29;14:1169752. doi: 10.3389/fimmu.2023.1169752. eCollection 2023.

    PubMed 37313403

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy in people with Treatment-naive Advanced Non-small Cell Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: Up to 2 approximately years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03856411, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.

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