Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, Non-Small Cell Lung Cancer, Paclitaxel, Carboplatin, AMG 655
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).
Interventions
DRUGAMG 655
AMG 655 is a monoclonal antibody directed against TR-2.
OTHERAMG 655 placebo
Inactive dummy AMG 655 (to maintain blind)
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | Until disease progression |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities | Until disease progression |
Outcome results
None listed