NCT03856411

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

Completed Phase 3 Last updated 1 February 2023

What this trial tests

Phase 3 trial testing TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy in Treatment-naive Advanced Non-small Cell Lung Cancer in 465 participants. Completed in 9 January 2023.

Timeline

18 March 2019

Primary endpoint
31 August 2022

9 January 2023

Quick facts

Lead sponsor	Shanghai Junshi Bioscience Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	465
Start date	18 March 2019
Primary completion	31 August 2022
Estimated completion	9 January 2023
Sites	1 location across China

Drugs / interventions tested

• TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy — full drug profile →

Conditions studied

• Treatment-naive Advanced Non-small Cell Lung Cancer — all drugs for Treatment-naive Advanced Non-small Cell Lung Cancer →

Sponsor

Shanghai Junshi Bioscience Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Treatment-naive Advanced Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2022.
   Kaplon H, Chenoweth A, Crescioli S, Reichert JM. · · 2022 · cited 245× · PMID 35030985 · DOI 10.1080/19420862.2021.2014296
2. Toripalimab Plus Chemotherapy for Patients With Treatment-Naive Advanced Non-Small-Cell Lung Cancer: A Multicenter Randomized Phase III Trial (CHOICE-01).
   Wang Z, Wu L, Li B, Cheng Y, et al · · 2023 · cited 137× · PMID 36206498 · DOI 10.1200/jco.22.00727
3. The progress and challenge of anti-PD-1/PD-L1 immunotherapy in treating non-small cell lung cancer.
   Qu J, Mei Q, Liu L, Cheng T, et al · · 2021 · cited 62× · PMID 33643442 · DOI 10.1177/1758835921992968
4. The evolving immuno-oncology landscape in advanced lung cancer: first-line treatment of non-small cell lung cancer.
   Low JL, Walsh RJ, Ang Y, Chan G, et al · · 2019 · cited 45× · PMID 31497071 · DOI 10.1177/1758835919870360
5. EGFR exon 20 insertion mutations in advanced non-small-cell lung cancer: current status and perspectives.
   Hou J, Li H, Ma S, He Z, et al · · 2022 · cited 44× · PMID 35418149 · DOI 10.1186/s40364-022-00372-6
6. Advances in molecular pathology and therapy of non-small cell lung cancer.
   Huang Q, Li Y, Huang Y, Wu J, et al · · 2025 · cited 43× · PMID 40517166 · DOI 10.1038/s41392-025-02243-6
7. Toripalimab, a therapeutic monoclonal anti-PD-1 antibody with high binding affinity to PD-1 and enhanced potency to activate human T cells.
   Rajasekaran N, Wang X, Ravindranathan S, Chin DJ, et al · · 2024 · cited 21× · PMID 38400933 · DOI 10.1007/s00262-024-03635-3
8. 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.
   Zhong J, Fei K, Wu L, Li B, et al · · 2024 · cited 13× · PMID 39715755 · DOI 10.1038/s41392-024-02087-6