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

Contact Investigators or Research Sites near you

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Michael J. Kraut

Assarian Cancer Center
Novi, MI United States
3.93miles
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Robert A. Chapman

Henry Ford Medical Center-Columbus
Novi, MI United States
5.04miles
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Philip J. Stella

Hope Cancer Clinic
Livonia, MI United States
5.62miles
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Philip J. Stella

Saint Mary Mercy Hospital
Livonia, MI United States
5.62miles
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Antoinette J. Wozniak

Weisberg Cancer Treatment Center
Farmington Hills, MI United States
8.68miles
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Michael J. Stender

Botsford General Hospital
Farmington, MI United States
8.68miles
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Philip J. Stella

IHA Hematology Oncology Consultants-Canton
Canton, MI United States
9.37miles
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Philip J. Stella

Saint Joseph Mercy Canton Health Center
Canton, MI United States
9.37miles
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Robert A. Chapman

Henry Ford West Bloomfield Hospital
West Bloomfield, MI United States
9.51miles
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Recruitment Status: Open


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