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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03513666
Recruitment Status : Active, not recruiting
First Posted : May 1, 2018
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

Study Description
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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
NSCLC Combination Product: Drug intervention Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : April 9, 2018
Actual Primary Completion Date : October 22, 2019
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 12 weeks ]
    The primary endpoint is the antitumor activities in this study


Secondary Outcome Measures :
  1. PFS [ Time Frame: 18 months ]
    Progression free survival (PFS)

  2. OS [ Time Frame: 18 months ]
    Overall survival (OS)

  3. DOR [ Time Frame: 18 months ]
    Duration of response (DOR)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513666


Locations
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China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
China, Shanghai
Shanghai Pulmonary Hospita
Shanghai, Shanghai, China
China, Shanxi
Tangdu Hospital
Xi'an, Shanxi, China
China, Zhejiang
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China, 310003
China, Zhengjiang
Zhengjiang Cancer Hospital
Hangzhou, Zhengjiang, China, 310022
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
More Information
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT03513666    
Other Study ID Numbers: JS001-PII-LC-001
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes