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

NCT00791154 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2024-08-23

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • NantCell, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-02
Primary Completion
2010-02-02
Completion
2013-05-01

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791154 on ClinicalTrials.gov