Phase II Trial of Carboplatin and Pemetrexed +/- OGX-427 in Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

April 19, 2017

Study Completion Date

April 19, 2017

Conditions
Non Squamous Non Small Cell Lung Cancer
Interventions
DRUG

OGX-427

Three loading doses of 600mg OGX-427 will be administered intravenously (IV) during a 9 day period. Then 600mg IV OGX-427 will be given weekly on Days 1, 8 and 15 of each 21 day cycle prior to the administration of pemetrexed (500mg/m\^2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle for a maximum of four treatment cycles. Patients who respond to treatment or have stable disease will continue to receive 600 mg IV OGX-427 plus 500mg/m2 IV pemetrexed weekly until toxicity or disease progression.

DRUG

Placebo

Three loading doses of placebo will be administered intravenously (IV) during a 9 day period. Then placebo (IV) will be given weekly on Days 1, 8 and 15 of each 21 day cycle prior to the administration of pemetrexed (500mg/m\^2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle for a maximum of four treatment cycles. Patients who respond to treatment or have stable disease will continue to receive placebo (IV) plus 500mg/m2 IV pemetrexed weekly until toxicity or disease progression.

Trial Locations (16)

20817

Center for Cancer and Blood Disorders, Bethesda

23230

Virginia Cancer Institute, Richmond

23601

Peninsula Cancer Institute, Newport News

29210

South Carolina Oncology Associates, Columbia

32804

Florida Hospital Cancer Insitute, Orlando

33705

Florida Cancer Specialists-North, St. Petersburg

33916

Florida Cancer Specialists-South, Fort Myers

37203

Tennessee Oncology, Nashville

37404

Tennessee Oncology - Chattanooga, Chattanooga

40207

Baptist Hospital East, Louisville

45242

Oncology Hematology Care, Inc., Cincinnati

64132

Research Medical Center, Kansas City

68114

Nebraska Methodist Hospital, Omaha

76104

The Center for Cancer and Blood Disorders, Fort Worth

80218

Rocky Mountain Cancer Center, Denver

07932

Hematology-Oncology Associates of Northern NJ, Morristown

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Achieve Life Sciences

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER