Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads
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|ClinicalTrials.gov Identifier: NCT03023904|
Recruitment Status : Withdrawn (Research cancelled)
First Posted : January 18, 2017
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non-Small Cell Lung Carcinoma Stage IV Non-Small Cell Lung Cancer||Biological: Nivolumab Other: Laboratory Biomarker Analysis||Phase 2|
I. To assess the objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
I. To assess the progression-free survival (PFS). II. To assess the overall survival (OS). III. To correlate response and mutation load with PD-L1 status (5% and 1% cutoffs).
IV. To assess clinical benefit (responses and stable disease lasting >= 6 months).
V. To assess the response rate in mutation-defined subgroups, including subjects with >= 25 mutations/mutational burden (MB) and >= 30 mutations/MB.
VI. To correlate the type of mutations with response.
Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 2 weeks for up to 2 years (104 weeks) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 35 days and then every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads|
|Actual Study Start Date :||December 29, 2017|
|Estimated Primary Completion Date :||July 30, 2019|
|Estimated Study Completion Date :||July 30, 2020|
Experimental: Treatment (nivolumab)
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 2 weeks for up to 2 years (104 weeks) in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Objective Response Rate defined as the number of subjects with a best overall response of complete response or partial response divided by the number of subjects that receive nivolumab as assessed by RECIST 1.1 [ Time Frame: Up to 6 months ]
- Overall survival [ Time Frame: From date of enrollment to date of death due to any cause, assessed up to 2 years ]
- Progression Free Survival as determined by RECIST 1.1 [ Time Frame: From date of enrollment until first date of documented progression or death due to any cause, assessed up to 2 years ]
- Mutation load as determined by FoundationOne testing [ Time Frame: Up to 2 years ]
- Incidence of adverse events (AEs) graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 100 days after the last dose of study drug ]
- PD-L1 expression as determined by immunohistochemistry [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023904
|Principal Investigator:||Douglas Johnson, M.D.||Vanderbilt-Ingram Cancer Center|