This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)." Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC. Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
213
AMG 479 is administered to subjects
Etoposide is administered to subjects
Placebo is administered with Carboplatin and Etoposide
AMG 102 is administered to subjects
Carboplatin is administered to some subjects in combination
Cisplatin is administered to some subjects in combination
Overall Survival in Ganitumab Treated Subjects -Phase 2
The primary efficacy endpoint was overall survival, defined as time from randomization to death from any cause
Time frame: Time from randomization to death from any cause, approximately 14 months
Overall Survival in Rilotumumab Treated Subjects-Phase 2
The primary efficacy endpoint is overall survival, defined as time from randomization to death from any cause
Time frame: Time from randomization to death from any cause, approximately 14 months
Number of Subjects With Dose Limiting Toxicities-Phase 1
For Part 1, DLTs were defined as the incidence during the first 21 days of starting study treatment of any Grade 3 or higher hematologic or non-hematologic toxicity related to AMG 479 or AMG 102, or the combination of AMG 479 or AMG 102 with chemotherapy, except for lymphocytopenia and anemia. DLTs did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, increased AST or ALT, or pulmonary embolism unless specific criteria were met as stated in protocol section 6.1.3.2.
Time frame: First 21 days after start of study treatment
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