Tremelimumab and Durvalumab With or Without Radiation Therapy in Patients With Relapsed Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT02701400 |
Recruitment Status :
Completed
First Posted : March 8, 2016
Results First Posted : June 22, 2021
Last Update Posted : June 22, 2021
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Tracking Information | ||||
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First Submitted Date ICMJE | February 23, 2016 | |||
First Posted Date ICMJE | March 8, 2016 | |||
Results First Submitted Date ICMJE | November 5, 2020 | |||
Results First Posted Date ICMJE | June 22, 2021 | |||
Last Update Posted Date | June 22, 2021 | |||
Actual Study Start Date ICMJE | April 14, 2016 | |||
Actual Primary Completion Date | August 7, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Change From Baseline in the Proportion of Lymphocyte Subset (CD8+ICOS+) Between Baseline and On-Treament (End of Cycle 1) [ Time Frame: Result presented for assessment at baseline and the end of cycle 1. ] Change in circulating and tumor-infiltrating lymphocytes between baseline and on-treatment samples at the end of Cycle 1. The proportion was calculated as the number of specific lymphocytes subset out of the total number of lymphocytes at baseline compared to the same proportion at the end of cycle 1.
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | ||||
Brief Title ICMJE | Tremelimumab and Durvalumab With or Without Radiation Therapy in Patients With Relapsed Small Cell Lung Cancer | |||
Official Title ICMJE | A Randomized Study of Tremelimumab Plus Durvalumab Combination With or Without Radiation in Relapsed Small Cell Lung Cancer | |||
Brief Summary | This randomized clinical trial studies how well tremelimumab and durvalumab with or without radiation therapy works in treating patients with small cell lung cancer that has returned after a period of improvement. Monoclonal antibodies, such as tremelimumab and durvalumab, may limit the ability of tumor cells to grow and spread by enhancing immune function. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tremelimumab and durvalumab together with radiation therapy may lead to improved clinical benefit. | |||
Detailed Description | PRIMARY OBJECTIVE: I. To assess the efficacy (progression free survival [PFS] and objective response rate [ORR]) of combined immune checkpoint inhibitor therapy as treatment for relapsed small-cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To assess the impact of antigen priming using radiation therapy (XRT) on the efficacy of immune checkpoint inhibitors. II. To determine immune related objective response rate. III. To estimate overall survival measured as time from randomization to death from any cause. TERTIARY OBJECTIVES: I. To characterize tumor infiltrating lymphocytes (TILs) and programmed cell death 1 ligand 1 (PD-L1)/programmed cell death 1 (PD1) expression in paired tumor biopsies at baseline, end of cycle 2 and at the time of progression. II. To determine dynamic changes in cell free deoxyribonucleic acid (DNA) (cfDNA) and the immunophenotype of peripheral blood repertoire of circulating lymphocytes using multiparameter flow cytometry. III. To determine changes in circulating cytokine mediators of inflammation and immunity using Luminex assay. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive tremelimumab intravenously (IV) over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation. ARM II: Patients undergo radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I. After completion of study treatment, patients are followed up periodically. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Recurrent Small Cell Lung Carcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Pakkala S, Higgins K, Chen Z, Sica G, Steuer C, Zhang C, Zhang G, Wang S, Hossain MS, Nazha B, Beardslee T, Khuri FR, Curran W, Lonial S, Waller EK, Ramalingam S, Owonikoko TK. Durvalumab and tremelimumab with or without stereotactic body radiation therapy in relapsed small cell lung cancer: a randomized phase II study. J Immunother Cancer. 2020 Dec;8(2):e001302. doi: 10.1136/jitc-2020-001302. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
18 | |||
Original Estimated Enrollment ICMJE |
20 | |||
Actual Study Completion Date ICMJE | August 7, 2020 | |||
Actual Primary Completion Date | August 7, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02701400 | |||
Other Study ID Numbers ICMJE | IRB00086004 NCI-2016-00026 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) ESR-14-10531 ( Other Identifier: AstraZeneca ) Winship3112-15 ( Other Identifier: Emory University/Winship Cancer Institute ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Taofeek K. Owonikoko, Emory University | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Emory University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | AstraZeneca | |||
Investigators ICMJE |
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PRS Account | Emory University | |||
Verification Date | May 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |