Docetaxel, Ramucirumab, and Pembrolizumab for the Treatment of Metastatic or Recurrent Non-small Cell Lung Cancer in Patients who have Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade Therapy

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT04340882
Trial Phases:	Phase II	Protocol IDs:	WINSHIP4950-20 (primary) NCI-2020-01134
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04340882

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 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 mass cytometry coupled to blood mass cytometry, in paired biopsies before and at the end of treatment.

OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes, ramucirumab IV over 60 minutes, and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan throughout the trial. Patients may also undergo collection of blood and tissue samples throughout the trial.

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
winshipcancer.emory.edu

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