A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Other: AMG 655 placebo
- Registration Number
- NCT00534027
- Lead Sponsor
- Amgen
- Brief Summary
Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
-
Disease Related
- Histologically or cytologically confirmed non-small cell lung cancer.
- Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
- Planning to receive up to 6 cycles of chemotherapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
- Men or women > 18 years of age Ethical
- Adequate Hematological, renal, hepatic and coagulation function General
- Plan to begin protocol specific therapy < 7 days after enrollment/randomization
-
Disease Related
- Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
- Prior chemotherapy as follows:
- Any prior chemotherapy for advanced non-small cell lung cancer
- Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
- Any prior chemoradiation.
- Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
- Other abnormal medical conditions
- Documented myocardial infarction or unstable/uncontrolled cardiac condition
- History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
- Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 AMG 655 Low Dose AMG 655 with paclitaxel/carboplatin Arm 3 AMG 655 placebo Placebo with paclitaxel/carboplatin Arm 1 AMG 655 AMG 655 High doseplus paclitaxel/carboplatin
- Primary Outcome Measures
Name Time Method Progression free survival Until disease progression
- Secondary Outcome Measures
Name Time Method Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities Until disease progression