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

JS001-PII-LC-001

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

2018-04-09

2022-08-12

2022-08-12

Completed

Early phase I

40

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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2023-08-23