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JS001: A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment

Sponsor
Shanghai Junshi Bioscience Co., Ltd. (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03513666
Collaborator
(none)
40
Enrollment
5
Locations
1
Arm
35.7
Anticipated Duration (Months)
8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Drug intervention
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Toripalimab 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
Actual Study Start Date :
Apr 9, 2018
Actual Primary Completion Date :
Oct 22, 2019
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment arm

Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy

Combination Product: Drug intervention
anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [12 weeks]

    The primary endpoint is the antitumor activities in this study

Secondary Outcome Measures

  1. PFS [18 months]

    Progression free survival (PFS)

  2. OS [18 months]

    Overall survival (OS)

  3. DOR [18 months]

    Duration of response (DOR)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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:
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Province Hospital Nanjing Jiangsu China 210029
2 Shanghai Pulmonary Hospita Shanghai Shanghai China
3 Tangdu Hospital Xi'an Shanxi China
4 The First Affiliated Hospital of Medical School of Zhejiang University Hangzhou Zhejiang China 310003
5 Zhengjiang Cancer Hospital Hangzhou Zhengjiang China 310022

Sponsors and Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03513666
Other Study ID Numbers:
  • JS001-PII-LC-001
First Posted:
May 1, 2018
Last Update Posted:
Sep 30, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 30, 2020