To study the effect of AMG 479 or AMG 102 in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
- Conditions
- Health Condition 1: null- Lung CancerSmall Cell Lung CancerSolid TumorsExtensive-stage Small Cell Lung CancerHealth Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lungHealth Condition 3: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2009/091/000149
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 204
Key Exclusion Criteria
Prior chemotherapy, chemoradiation, or investigational agent for SCLC
Prior radiotherapy to >25% of the bone marrow
Symptomatic or untreated central nervous system metastases (with exceptions)
Currently or previously treated with biologic, immunologic or other therapies for SCLC
Current serious or nonhealing wound or ulcer
History of prior concurrent other malignancy (with exceptions)
Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI
Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity
Key Exclusion Criteria
Prior chemotherapy, chemoradiation, or investigational agent for SCLC
Prior radiotherapy to 25% of the bone marrow
Symptomatic or untreated central nervous system metastases (with exceptions)
Currently or previously treated with biologic, immunologic or other therapies for SCLC
Current serious or nonhealing wound or ulcer
History of prior concurrent other malignancy (with exceptions)
Any clinically significant medical condition other than cancer (eg, cardiovascular disease or chronic obstructive pulmonary disease), which could interfere with the safe delivery of study treatment or risk of toxicity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 2: To estimate the relative treatment effect of platinum-based chemotherapy plus AMG 479, and of platinum-based chemotherapy plus AMG 102, compared to platinum-based chemotherapy plus placebo as measured by the respective HR for overall survival <br/ ><br>Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs). Part 2: Overall survival (OS) <br/ ><br>Timepoint: Time Frame: Length of study <br/ ><br> <br/ ><br>The subject accrual period is estimated to be approximately 6 to 12 months for Part 1, <br/ ><br>and approximately 18 months for Part 2. The maximum duration of <br/ ><br>the study is approximately 66 months (from the first subject enrolled in Part 1 until <br/ ><br>approximately 36 months from the last subject enrolled in Part 2). <br/ ><br>
- Secondary Outcome Measures
Name Time Method Incidence of adverse events and laboratory abnormalities not defined as DLTs. <br/ ><br>Incidence of anti-AMG 479 and anti-AMG 102 antibody formation <br/ ><br>Pharmacokinetics (Cmax and Cmin for AMG 102 and AMG 479) <br/ ><br>ORR, DOR, TTP, PFS and OS rates at 10, 12, 24 and 36 months <br/ ><br>EORTC QLQ-C30 and EORTC QLQ-LC13 scoresTimepoint: Time Frame: Length of study <br/ ><br> <br/ ><br>The subject accrual period is estimated to be approximately 6 to 12 months for Part 1, <br/ ><br>and approximately 18 months for Part 2. The maximum duration of <br/ ><br>the study is approximately 66 months (from the first subject enrolled in Part 1 until <br/ ><br>approximately 36 months from the last subject enrolled in Part 2). <br/ ><br>