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Completed

NCT Number: NCT03513666

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

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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jiangsu Province Hospital, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Drug intervention

Combination Product

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

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 12 weeks

    The primary endpoint is the antitumor activities in this study

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study 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

Acronym: JS001

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 1, 2018
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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