Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Multicenter, Open Label, Randomized Study of AMG 951 in Subjects With Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated With Chemotherapy With or Without Bevacizumab
This is a phase 2 multicenter, open label, randomized study of AMG 951 (rhApo2L/TRAIL) in
subjects with previously untreated stage IIIb/IV NSCLC treated with chemotherapy with or
without bevacizumab.
Subjects will be assigned to a set of treatment groups depending on their eligibility to
receive bevacizumab. Subjects with squamous NSCLC and/or CNS metastases will not be eligible
to receive bevacizumab and will be assigned to either cohort A or B (provided all other
eligibility criteria are met). Subjects who are eligible to receive bevacizumab will be
assigned to cohort C, D or E. Cohorts are defined as follows:
Subjects with squamous NSCLC or CNS mets:
Cohort A: Chemotherapy alone Cohort B: Chemotherapy plus 8 mg/kg AMG 951 for 5 days
Subjects without squamous NSCLC and without CNS mets:
Cohort C: Chemotherapy and bevacizumab Cohort D: Chemotherapy, bevacizumab plus 8 mg/kg AMG
951 for 5 days Cohort E: Chemotherapy, bevacizumab plus up to 20 mg/kg AMG 951 for 2 days
Approximately forty subjects will be recruited to each cohort.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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