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CompletedNCT03513666JS001Updated Aug 23, 2023

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

A Phase 2 interventional study of Drug intervention in NSCLC, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Completed at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-23.

Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • NSCLC
03

In context

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.

04

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:

  • Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:
  • Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;
  • No exon 20 T790M mutation after failure of EGFR-TKI therapy;
  • At least one measurable lesion (in accordance with RECIST 1.1);

Exclusion criteria

Exclusion Criteria:

Patients who fulfill any of the following criteria must be excluded from the study:

  • Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%;
  • Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;
  • Previous systemic chemotherapy for advanced NSCLC;
  • EGFR-TKI therapy within two weeks prior to enrollment;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    treatment arm

    Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy

    Combination Product: Drug intervention

Interventions

  • Combination productDrug intervention

    anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

    The primary endpoint is the antitumor activities in this study

    Time frame: 12 weeks

Secondary outcomes

  1. PFS

    Progression free survival (PFS)

    Time frame: 18 months

  2. OS

    Overall survival (OS)

    Time frame: 18 months

  3. DOR

    Duration of response (DOR)

    Time frame: 18 months

07

Study locations

5 sites
  • Jiangsu Province Hospital
    Nanjing, Jiangsu 210029, China
  • Shanghai Pulmonary Hospita
    Shanghai, Shanghai, China
  • Tangdu Hospital
    Xi'an, Shanxi, China
  • The First Affiliated Hospital of Medical School of Zhejiang University
    Hangzhou, Zhejiang 310003, China
  • Zhengjiang Cancer Hospital
    Hangzhou, Zhengjiang 310022, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03513666
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Responsible party
Sponsor
First posted
May 1, 2018
Start date
Apr 9, 2018
Primary completion
Aug 12, 2022
Completion
Aug 12, 2022
Last update
Aug 23, 2023

Oversight

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

Not currently enrolling

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

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