A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Adults With Previously Untreated, Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01268059|
Recruitment Status : Completed
First Posted : December 29, 2010
Last Update Posted : March 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Carboplatin/Paclitaxel/MEDI-575 Drug: Carboplatin/Paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
|Active Comparator: MEDI-575 Dose Determination||
Subjects will receive carboplatin/paclitaxel and MEDI-575 every 21 days for up to 6 cycles. MEDI-575 may continue alone after 6 cycles unless there is evidence of disease progression or intolerance of study treatment.
|Active Comparator: Arm A||
Subjects will receive carboplatin/paclitaxel (paclitaxel 200 mg/m2 and carboplatin AUC=6 mg/mL*min) for up to 6 cycles unless there is evidence of disease progression or intolerance of study treatment.
|Active Comparator: Arm B||
Subjects will receive carboplatin/paclitaxel (paclitaxel 200 mg/m2 and carboplatin AUC=6mg/mL*min) plus MEDI-575 at dose determined in the Dose Determination Phase. Carboplatin/paclitaxel and MEDI-575 to be given once every 21 days as an IV infusion for up to 6 cycles. MEDI-575 may continue alone after 6 cycles unless there is evidence of disease progression or intolerance of study treatment.
- Evaluate safety profile of MEDI-575 when used in combination with carboplatin/paclitaxel [ Time Frame: 21 days ]Subjects will be evaluated while receiving carboplatin/paclitaxel plus MEDI-575 to evaluate dose.
- Evaluate the progression-free survival of subjects following treatment [ Time Frame: 126 days ]Subjects will be randomized into two arms and receive either carboplatin/paclitaxel or carboplatin/paclitaxel plus MEDI-575.
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): NCT01268059
Show 29 Study Locations
|Study Director:||Naimish Pandya, MD||MedImmune LLC|