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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03513666
Other study ID # JS001-PII-LC-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 9, 2018
Est. completion date August 12, 2022

Study information

Verified date August 2023
Source Shanghai Junshi Bioscience Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 12, 2022
Est. primary completion date August 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China The First Affiliated Hospital of Medical School of Zhejiang University Hangzhou Zhejiang
China Zhengjiang Cancer Hospital Hangzhou Zhengjiang
China Jiangsu Province Hospital Nanjing Jiangsu
China Shanghai Pulmonary Hospita Shanghai Shanghai
China Tangdu Hospital Xi'an Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) The primary endpoint is the antitumor activities in this study 12 weeks
Secondary PFS Progression free survival (PFS) 18 months
Secondary OS Overall survival (OS) 18 months
Secondary DOR Duration of response (DOR) 18 months
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