Phase II Trial of Continuation Therapy in Advanced NSCLC

Status Completed

Clinical Trial Summary

This is a single-arm phase II study of continuation immunotherapy with pembrolizumab following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor.

Clinical Trial Description

OUTLINE: This is a multi-center study. Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m2 IV D1 and D8 every three weeks, docetaxel 75mg/m2 IV D1 every three weeks, or pemetrexed 500mg/m2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity. Administration Sequence: First Sequence - Pembrolizumab 200mg IV on Day 1 (cycle = 21 days) Administration Sequence: Second Sequence - Gemcitabine 1000mg/m^2 IV on Days 1,8 (cycle = 21 days) - Docetaxel 75mg/^2 IV on Days 1,8 (cycle = 21 days) - Pemetrexed 500mg/m^2 IV on Day 1 (cycle -= 21 days) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03083808
Study type	Interventional
Source	Big Ten Cancer Research Consortium
Contact
Status	Completed
Phase	Phase 2
Start date	March 20, 2017
Completion date	March 3, 2022

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