Study Complete
Sponsor ID
20060534

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

Sponsor ID
20060534
Clinicaltrials.gov ID
NCT00791154
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 479
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
204
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.