Phase 2 study of Pembrolizumab plus pemetrexed for elderly patients with non-squamous non-small cell lung cancer with PD-L1 tumor proportion score of less than 50%: CJLSG1901 - NMC-CJLSG1901

Kogure Yoshihito0 sites49 target enrollmentMay 25, 2020

Overview

No summary available.

Registry

who.int

Start Date

May 25, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kogure Yoshihito

•1\)Non\-squamous non\-small cell lung cancer (NSCLC) confirmed by histology or cytology.
•2\)Not received prior systemic treatment with stage IV, or recurrent NSCLC.
•Subjects who received adjuvant therapy are eligible if the adjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
•3\)PD\-L1 TPS of less than 50% with 22C3 antibody.
•4\)With at least one measurable lesion based on RECIST 1\.1\.
•5\)Age of 75 years or older on the day of informed consent.
•6\)ECOG Performance Status 0\-1\.
•7\)Without activating mutation in EGFR or ALK chromosomal translocation.
•8\)Absence of severe impairments of major organs.
•9\)Life expectancy of 12 weeks or more from the treatment start date.

•1\)Before the first dose of trial treatment:
•Had major surgery (\<3 weeks prior to the first dose)
•2\)Received radiation therapy to the lung that exceeds 30 Gy within 6 months of the first dose of the study treatment.
•3\)Completed palliative radiotherapy within 7 days of the first dose of the treatment.
•4\)Has received a live\-virus vaccination within 30 days of planned treatment initiation.
•Seasonal flu vaccines that do not contain live virus are permitted.
•5\)Has clinically active diverticulitis, intra\-abdominal abscess, GI obstruction, peritoneal carcinomatosis.
•6\)Has a history of malignancy except if the subject has undergone curative therapy without recurrence for 5 years since initiation of that therapy.
•7\)Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•8\)Previously had a severe hypersensitivity reaction to treatment with another mAb.