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

Phase 1

Terminated

• Conditions: Extensive-stage Small Cell Lung Cancer; Lung Cancer; Solid Tumors; Small Cell Lung Cancer
• Interventions: Drug: AMG 479; Drug: Etoposide; Drug: Placebo; Drug: AMG 102; Drug: Carboplatin; Drug: Cisplatin

• Registration Number: NCT00791154
• Lead Sponsor: NantCell, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Study Start: 2008-12-02
• Primary Completion: 2010-02-02
• Study Completion: 2013-05-01
• Disposition First Submitted: 2015-02-02
• Disposition First Submitted QC: 2015-02-02
• Disposition First Posted: 2015-02-19
• Results First Submitted: 2024-04-17
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Results First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM A	AMG 479	Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
ARM A	Etoposide	Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
ARM A	Cisplatin	Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
ARM C	Placebo	Blinded placebo and carboplatin or cisplatin and etoposide
ARM C	Etoposide	Blinded placebo and carboplatin or cisplatin and etoposide
ARM C	Carboplatin	Blinded placebo and carboplatin or cisplatin and etoposide
ARM A	Carboplatin	Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
ARM B	Etoposide	Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
ARM B	Carboplatin	Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
ARM B	Cisplatin	Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
ARM C	Cisplatin	Blinded placebo and carboplatin or cisplatin and etoposide
ARM B	AMG 102	Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide

Primary Outcome Measures

Name	Time	Method
Overall Survival in Ganitumab Treated Subjects -Phase 2	Time from randomization to death from any cause, approximately 14 months	The primary efficacy endpoint was overall survival, defined as time from randomization to death from any cause
Overall Survival in Rilotumumab Treated Subjects-Phase 2	Time from randomization to death from any cause, approximately 14 months	The primary efficacy endpoint is overall survival, defined as time from randomization to death from any cause
Number of Subjects With Dose Limiting Toxicities-Phase 1	First 21 days after start of study treatment	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.