Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093962
Show 80 Study Locations
|Study Chair:||Tillman Pearce, MD||Threshold Pharmaceuticals|
|Principal Investigator:||Jonathan Goldman, MD||UCLA-Dept of Medicine a Div of Hem/Onc|