A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
Study Details
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.
Protocol Summary
Part 2: To estimate the relative treatment effect of platinum-based chemotherapy and AMG 479, and of platinum-based chemotherapy and AMG 102, compared to platinum-based chemotherapy and placebo as measured by the respective HR for overall survival
Timeframe: Length of study
Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs). Part 2: Overall survival (OS)
Timeframe: Length of study
Incidence of adverse events and laboratory abnormalities not defined as DLTs.
Timeframe: Length of study
Incidence of anti-AMG 479 and anti-AMG 102 antibody formation
Timeframe: Length of study
Pharmacokinetics (Cmax and Cmin for AMG 102 and AMG 479)
Timeframe: Length of study
ORR, DOR, TTP, PFS and OS rates at 10, 12, 24 and 36 months
Timeframe: Length of study
EORTC QLQ-C30 and EORTC QLQ-LC13 scores
Timeframe: Length of study