NCT03513666: JS001

A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment

Completed Phase 2 Last updated 23 August 2023

What this trial tests

Phase 2 trial testing Drug intervention in NSCLC in 40 participants. Completed in 12 August 2022.

Timeline

9 April 2018

Primary endpoint
12 August 2022

12 August 2022

Quick facts

Lead sponsor	Shanghai Junshi Bioscience Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	9 April 2018
Primary completion	12 August 2022
Estimated completion	12 August 2022
Sites	5 locations across China

Drugs / interventions tested

• Drug intervention — full drug profile →

Conditions studied

• NSCLC — all drugs for NSCLC →

Sponsor

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

Who can join

Adults 18 to 75, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study

Publications & conference data

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

1. Toripalimab plus chemotherapy as second-line treatment in previously EGFR-TKI treated patients with EGFR-mutant-advanced NSCLC: a multicenter phase-II trial.
   Jiang T, Wang P, Zhang J, Zhao Y, et al · · 2021 · cited 79× · PMID 34650034 · DOI 10.1038/s41392-021-00751-9
2. Development of EGFR TKIs and Options to Manage Resistance of Third-Generation EGFR TKI Osimertinib: Conventional Ways and Immune Checkpoint Inhibitors.
   Wu L, Ke L, Zhang Z, Yu J, et al · · 2020 · cited 77× · PMID 33392095 · DOI 10.3389/fonc.2020.602762
3. Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China.
   Zhang L, Hao B, Geng Z, Geng Q. · · 2021 · cited 71× · PMID 35095833 · DOI 10.3389/fimmu.2021.730666
4. 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
5. Programmed cell death-ligand 2: A neglected but important target in the immune response to cancer?
   Solinas C, Aiello M, Rozali E, Lambertini M, et al · · 2020 · cited 61× · PMID 32622310 · DOI 10.1016/j.tranon.2020.100811
6. Second-line treatment of <i>EGFR</i> T790M-negative non-small cell lung cancer patients.
   Liao BC, Griesing S, Yang JC. · · 2019 · cited 31× · PMID 31803256 · DOI 10.1177/1758835919890286
7. Application of immune checkpoint inhibitors in EGFR-mutant non-small-cell lung cancer: from bed to bench.
   Jin R, Zhao J, Xia L, Li Q, et al · · 2020 · cited 29× · PMID 32565926 · DOI 10.1177/1758835920930333
8. Immunotherapy for EGFR-mutant advanced non-small-cell lung cancer: Current status, possible mechanisms and application prospects.
   Shi C, Wang Y, Xue J, Zhou X. · · 2022 · cited 27× · PMID 35935943 · DOI 10.3389/fimmu.2022.940288