Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-Sq NSCLC With PD-L1 < 50%: CJLSG1901 (NCT04396457) | Clinical Trial Compass
UnknownPhase 2
Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-Sq NSCLC With PD-L1 < 50%: CJLSG1901
Japan50 participantsStarted 2020-05-25
Plain-language summary
To evaluate the efficacy and safety of Pembrolizumab + Pemetrexed in elderly patients with non-squamous non-small cell lung cancer with Programmed cell death (PD) -ligand1 (L1) tumor proportion score (TPS) of less than 50%.
Who can participate
Age range75 Years
SexALL
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Inclusion criteria
✓. Non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology.
✓. 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.
✓. PD-L1 TPS of less than 50% with 22C3 antibody.
✓. With at least one measurable lesion based on RECIST 1.1.
✓. Age of 75 years or older on the day of informed consent.
✓. ECOG Performance Status 0-1.
✓. Without activating mutation in EGFR or ALK chromosomal translocation.
✓. Absence of severe impairments of major organs.
Exclusion criteria
✕. Before the first dose of trial treatment:
✕. Received radiation therapy to the lung that exceeds 30 Gy within 6 months of the first dose of the study treatment.
✕. Completed palliative radiotherapy within 7 days of the first dose of the treatment.
✕. Has received a live-virus vaccination within 30 days of planned treatment initiation.
✕. Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, peritoneal carcinomatosis.
What they're measuring
1
Overall response rate
Timeframe: Up to approximately 3 years
Trial details
NCT IDNCT04396457
SponsorNational Hospital Organization Nagoya Medical Center