A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment (JS001)

Shanghai Junshi Biosciences

Status and phase

Completed

Phase 2

Conditions

NSCLC

Treatments

Combination Product: Drug intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03513666

JS001-PII-LC-001

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;