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A Phase 2 Study of Docetaxel, Ramucirumab, and Pembrolizumab for Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer Who Progressed on Platinum-Doublet and PD-1 / PD-L1 Blockade

Status
Active
Cancer Type
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04340882
Protocol IDs
WINSHIP4950-20 (primary)
NCI-2020-01134
Study Sponsor
Emory University Hospital / Winship Cancer Institute

Summary

This phase II trial studies how well docetaxel, ramucirumab, and pembrolizumab works for the treatment of non-small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent) in patients who have progressed on platinum-doublet and PD-1 / PD-L1 blockade therapy. Drugs used in chemotherapy, such as docetaxel, 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. Ramucirumab may block new blood vessel growth to reduce tumor growth. Immunotherapy with 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 docetaxel, ramucirumab, and pembrolizumab may work better in shrinking lung cancer.

Objectives

PRIMARY OBJECTIVE:
I. To determine the anti-tumor efficacy of the combination treatment using the 6-month progression free survival rate (6-month progression free survival [PFS] rate) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

SECONDARY OBJECTIVES:
I. To determine the safety profile and tolerability of docetaxel and ramucirumab in combination with pembrolizumab in patients who progressed on platinum-based chemotherapy and PD-1 or PD-L1 checkpoint inhibitor given sequentially or in combination.
II. To determine immune related adverse events of the combination docetaxel, ramucirumab, and pembrolizumab.
III. To assess the overall response rate (ORR) of the combination docetaxel, ramucirumab, and pembrolizumab.
IV. To assess the overall survival (OS) of the combination docetaxel, ramucirumab, and pembrolizumab.

EXPLORATORY OBJECTIVES:
I. To correlate treatment response with PD-L1 22C3 expression, STK11 and KRAS mutation status.
II. To correlate treatment response with the doublet tumor mutation burden (TMB) and PD-L1 22C3 expression.
III. To perform an immunophenotypic analysis of circulating immune cells by mass cytometry before and after treatment and end of treatment (EOT).
IV. To analyze the tumor infiltrating immune cells by single cell ribonucleic acid (RNA) sequencing coupled to mass cytometry, in paired biopsies before and after treatment.

OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes, ramucirumab IV over 60 minutes, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, 12 weeks for 2 years, every 6 months for 3 years, and then annually for up to 10 years.

Treatment Sites in Georgia

Atlanta VA Medical Center


1670 Clairmont Road
Decatur, GA 30033
404-728-7680
www.atlanta.va.gov

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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