NCT02581943

Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer

Immune Response in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer and Performance Status of 2 Treated With a Combination of Pembrolizumab and Low Dose Weekly Carboplatin/Paclitaxel

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot phase II trial studies the effect of pembrolizumab with or without carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with carboplatin and paclitaxel may improve immune responses in patients with non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the immune effects of single agent pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel. II. Estimate the treatment response to single agent pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel. SECONDARY OBJECTIVES: I. Determine the toxicity and tolerability of pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel. II. Assess quality of life (QOL) in patients receiving single agent pembrolizumab and pembrolizumab combined with carboplatin and paclitaxel. III. Assess the association between immune response and clinical response. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. In both arms, courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 30 days and then every 8 weeks thereafter.

Conditions

• Recurrent Non-Small Cell Lung Carcinoma
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given IV
BIOLOGICAL	Pembrolizumab	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2016-06-17
• Primary completion: 2022-11-19
• Completion: 2022-12-28
• First posted: 2015-10-21
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study