Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Non-Small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT02950038|
Recruitment Status : Withdrawn
First Posted : October 31, 2016
Last Update Posted : February 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer, Nonsmall Cell, Stage I||Drug: Ibrutinib Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2019|
Experimental: Ibrutinib + Nivolumab
Ibrutinib administered by mouth daily in 28 day cycles.
Nivolumab administered by vein beginning with cycle 2, and given on Days 1 and 15 of every 28 day cycle.
560 mg given by mouth daily in a 28 day cycle.
3 mg/kg by vein beginning with Cycle 2 on Days 1 and 15 of every 28 day cycle.
- Response Rate in Participants with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) Treated with Ibrutinib Followed by a Combination of Ibrutinib and Nivolumab [ Time Frame: 8 weeks from start of combination therapy ]
Response rate defined as the sum of complete plus partial responses (CR+PR).
Response assessed by RECIST 1.1 criteria.
- Disease Control Rate [ Time Frame: 30 days after the last dose of study medication ]
Disease control rate defined as rate of stable disease + partial response + complete response.
Outcome measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
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): NCT02950038
|Principal Investigator:||John Heymach, MD, PHD||M.D. Anderson Cancer Center|