NCT03083808

Phase II Trial of Continuation Therapy in Advanced NSCLC

A Phase II Trial of Chemotherapy Plus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With PD-1 or PD-L1 Inhibitor: Big Ten Cancer Research Consortium BTCRC-LUN15-029

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Greg Durm, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200mg IV every 21 days \+ Physician's choice chemotherapy with one of the following every 21 days: * Docetaxel 75mg/m2 IV * Pemetrexed 500mg/m2 IV (non-squamous only) * Gemcitabine 1000mg/m2 IV on days 1 and 8

Timeline

• Start date: 2017-03-20
• Primary completion: 2021-12-14
• Completion: 2022-03-03
• First posted: 2017-03-20
• Last updated: 2023-08-24
• Results posted: 2022-06-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study