NCT04032418

Pembrolizumab Every 12 Weeks Versus Every 3 Weeks in Treating Patients With Non-small Cell Lung Cancer

Randomized Phase II Study of Pembrolizumab 200mg every12 Weeks Versus Every 3 Weeks in NSCLC With Clinical Benefit to Pembrolizumab Monotherapy: Multicenter International Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pembrolizumab given every 12 weeks works compared to every 3 weeks in treating patients with non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab every 12 weeks may provide similar disease control with fewer treatments for patients with non-small cell lung cancer when compared to every 3 weeks. Demonstrating that 12 week dosing is as effective as 3 week dosing may also have a significant impact when considering the cost required for these medications.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the 1-year progression-free survival rate with 200mg pembrolizumab administered every 3 weeks compared to 200mg pembrolizumab administered every 12 weeks. SECONDARY OBJECTIVES: I. To assess overall survival between the two treatment groups. II. To assess the serious adverse event profiles between the two treatment groups. EXPLORATORY OBJECTIVES: I. To evaluate circulating biomarkers of treatment response and resistance. II. To characterize fecal microbiotic profile and to correlate those results with tumor characteristics and antitumor immune responses. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive pembrolizumab IV over 30 minutes every 12 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks for at least 12 months.

Conditions

• Lung Non-Small Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2020-08-13
• Primary completion: 2025-03-14
• Completion: 2026-03-14
• First posted: 2019-07-25
• Last updated: 2025-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study