QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer
NCT ID: NCT00791154
Last Updated: 2024-08-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
213 participants
INTERVENTIONAL
2008-12-02
2013-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ARM A
Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
AMG 479
AMG 479 is administered to subjects
Etoposide
Etoposide is administered to subjects
Carboplatin
Carboplatin is administered to some subjects in combination
Cisplatin
Cisplatin is administered to some subjects in combination
ARM B
Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
Etoposide
Etoposide is administered to subjects
AMG 102
AMG 102 is administered to subjects
Carboplatin
Carboplatin is administered to some subjects in combination
Cisplatin
Cisplatin is administered to some subjects in combination
ARM C
Blinded placebo and carboplatin or cisplatin and etoposide
Etoposide
Etoposide is administered to subjects
Placebo
Placebo is administered with Carboplatin and Etoposide
Carboplatin
Carboplatin is administered to some subjects in combination
Cisplatin
Cisplatin is administered to some subjects in combination
Interventions
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AMG 479
AMG 479 is administered to subjects
Etoposide
Etoposide is administered to subjects
Placebo
Placebo is administered with Carboplatin and Etoposide
AMG 102
AMG 102 is administered to subjects
Carboplatin
Carboplatin is administered to some subjects in combination
Cisplatin
Cisplatin is administered to some subjects in combination
Eligibility Criteria
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Inclusion Criteria
* Extensive disease, defined by at least one of the following:
* No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
* Extrathoracic metastases
* Malignant pericardial or pleural effusion
* Contralateral hilar adenopathy
* Measurable or nonmeasurable disease, as defined by modified RECIST
* Eastern Cooperative Oncology Group (ECOG) status 0 or 1
* ≥18 years old
* Life expectancy (with therapy) ≥3 months
* Adequate hematologic, hepatic, coagulation, renal, and metabolic function
* Diabetes, if present, must be controlled, with glycosylated hemoglobin (HbA1C) ≤ 8% and fasting glucose levels ≤160 mg/dL
Exclusion Criteria
* Prior radiotherapy to \>25% of the bone marrow
* Symptomatic or untreated central nervous system metastases (with exceptions)
* Currently or previously treated with biologic, immunologic or other therapies for SCLC
* Current serious or nonhealing wound or ulcer
* History of prior concurrent other malignancy (with exceptions)
* Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI
* Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity
18 Years
ALL
No
Sponsors
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NantCell, Inc.
INDUSTRY
Responsible Party
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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NCT00791154
Identifier Type: OTHER
Identifier Source: secondary_id
QUILT-2.013
Identifier Type: -
Identifier Source: org_study_id
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