NSCLC Clinical Trial
— JS001Official 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
Verified date | August 2023 |
Source | Shanghai Junshi Bioscience Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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; |
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 |
Lead Sponsor | Collaborator |
---|---|
Shanghai Junshi Bioscience Co., Ltd. |
China,
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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