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

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 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

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;