NCT00791154

QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer

QUILT-2.013 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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: NantCell, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lung Cancer
• Small Cell Lung Cancer
• Solid Tumors
• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AMG 479	AMG 479 is administered to subjects
DRUG	Etoposide	Etoposide is administered to subjects
DRUG	Placebo	Placebo is administered with Carboplatin and Etoposide
DRUG	AMG 102	AMG 102 is administered to subjects
DRUG	Carboplatin	Carboplatin is administered to some subjects in combination
DRUG	Cisplatin	Cisplatin is administered to some subjects in combination

Timeline

• Start date: 2008-12-02
• Primary completion: 2010-02-02
• Completion: 2013-05-01
• First posted: 2008-11-14
• Last updated: 2024-08-23
• Results posted: 2024-08-23