Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02093962|
Recruitment Status : Terminated (At the interim analysis, the futility boundary was not met and the study was stopped due to insufficient efficacy.)
First Posted : March 21, 2014
Results First Posted : August 11, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: TH-302 combination with pemetrexed Drug: Matched placebo in combination with pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||265 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination With TH-302 vs. Pemetrexed in Combination With Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||May 2016|
Experimental: TH-302 and pemetrexed
TH-302 in combination with pemetrexed
Drug: TH-302 combination with pemetrexed
400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
Active Comparator: Placebo and pemetrexed
Matching placebo in combination with pemetrexed
Drug: Matched placebo in combination with pemetrexed
Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
- Overall Survival [ Time Frame: 2 years ]To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo
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): NCT02093962
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|Study Chair:||Tillman Pearce, MD||Threshold Pharmaceuticals|
|Principal Investigator:||Jonathan Goldman, MD||UCLA-Dept of Medicine a Div of Hem/Onc|