Last updated on December 2018

Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer


Brief description of study

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among patients treated with durvalumab (MEDI4736) plus tremelimumab.

SECONDARY OBJECTIVES:

I. To estimate the duration of response (DoR) among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1.

II. To estimate the duration of response (DoR) per immune-related response criteria among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1.

III. To evaluate overall survival (OS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

IV. To evaluate investigator-assessed progression-free survival (IA-PFS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

V. To evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

VI. To evaluate the frequency and severity of toxicities associated with durvalumab (MEDI4736) plus tremelimumab.

TERTIARY OBJECTIVES:

I. To explore the association of potential predictive markers identified in S1400A, with response and progression-free survival (PFS).

II. To explore the association of PD-L1 expression status with response and PFS.

III. To contribute to an ongoing serum and tumor bank in S1400.

OUTLINE

Patients receive tremelimumab intravenously (IV) over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years, and then at the end of year 3.

Clinical Study Identifier: NCT03373760

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Enumclaw, WA United States
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Saint Francis Hospital

Federal Way, WA United States
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Northwest Cancer Clinic

Kennewick, WA United States
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Saint Clare Hospital

Lakewood, WA United States
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Skagit Valley Hospital

Mount Vernon, WA United States
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Jefferson Healthcare

Port Townsend, WA United States
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Peninsula Cancer Center

Poulsbo, WA United States
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Valley Medical Center

Renton, WA United States
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Legacy Salmon Creek Hospital

Vancouver, WA United States
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United Hospital Center

Bridgeport, WV United States
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Saint Mary's Medical Center

Huntington, WV United States
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WVUH-East City Hospital

Martinsburg, WV United States
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Camden-Clark Memorial Hospital

Parkersburg, WV United States
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Marshfield Clinic-Chippewa Center

Chippewa Falls, WI United States
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Sacred Heart Hospital

Eau Claire, WI United States
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Aurora Health Center-Fond du Lac

Fond Du Lac, WI United States
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Aurora Cancer Care-Grafton

Grafton, WI United States
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Aurora BayCare Medical Center

Green Bay, WI United States
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Mercy Health System

Janesville, WI United States
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UW Cancer Center Johnson Creek

Johnson Creek, WI United States
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Holy Family Memorial Hospital

Manitowoc, WI United States
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Marshfield Clinic

Marshfield, WI United States
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Saint Joseph's Hospital

Marshfield, WI United States
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Community Memorial Hospital

Menomonee Falls, WI United States
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Aurora Cancer Care-Milwaukee

Milwaukee, WI United States
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Aurora Sinai Medical Center

Milwaukee, WI United States
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Cancer Center of Western Wisconsin

New Richmond, WI United States
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Green Bay Oncology - Oconto Falls

Oconto Falls, WI United States
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Aurora Cancer Care-Racine

Racine, WI United States
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HSHS Saint Nicholas Hospital

Sheboygan, WI United States
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Saint Clare's Hospital

Weston, WI United States
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Aspirus UW Cancer Center

Wisconsin Rapids, WI United States
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Billings Clinic-Cody

Cody, WY United States
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Welch Cancer Center

Sheridan, WY United States
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