Last updated on September 2018

Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers


Brief description of study

This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) in patients with advanced stage refractory squamous cell carcinoma (SCCA) of the lung randomized to nivolumab plus ipilimumab versus nivolumab.

SECONDARY OBJECTIVES:

I. To compare investigator-assessed progression-free survival (IA-PFS) in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab versus nivolumab.

II. To compare the response rates (confirmed and unconfirmed, complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among patients randomized to receive nivolumab plus ipilimumab versus nivolumab.

III. To compare the response rates (confirmed only, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab versus nivolumab.

IV. To evaluate the frequency and severity of toxicities associated with nivolumab plus ipilimumab versus nivolumab.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To evaluate if there is a differential treatment effect on OS, IA-PFS, and response by tumor programmed death-ligand 1 (PD-L1) expression status.

II. To examine patient reported outcomes by treatment arm.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment but prior to disease progression, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years. After disease progression, patients are followed up every 6 months for 2 years and at end of year 3 after sub-study registration.

Clinical Study Identifier: NCT02785952

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Williamsport, PA United States
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Lankenau Medical Center

Wynnewood, PA United States
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AnMed Health Cancer Center

Anderson, SC United States
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Gibbs Cancer Center-Gaffney

Gaffney, SC United States
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Saint Francis Hospital

Greenville, SC United States
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Greenville Memorial Hospital

Greenville, SC United States
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Saint Francis Cancer Center

Greenville, SC United States
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Spartanburg Medical Center

Spartanburg, SC United States
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Lexington Medical Center

West Columbia, SC United States
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Avera Cancer Institute

Sioux Falls, SD United States
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Memorial Hospital

Chattanooga, TN United States
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Memorial GYN Plus

Ooltewah, TN United States
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Brooke Army Medical Center

Fort Sam Houston, TX United States
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Ben Taub General Hospital

Houston, TX United States
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M D Anderson Cancer Center

Houston, TX United States
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University Medical Center

Lubbock, TX United States
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Sandra L Maxwell Cancer Center

Cedar City, UT United States
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Logan Regional Hospital

Logan, UT United States
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Riverton Hospital

Riverton, UT United States
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LDS Hospital

Salt Lake City, UT United States
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South Jordan Health Center

South Jordan, UT United States
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Virginia Cancer Institute

Richmond, VA United States
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Harrison Medical Center

Bremerton, WA United States
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Saint Elizabeth Hospital

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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