KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy
NCT ID: NCT01487174
Last Updated: 2022-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
8 participants
INTERVENTIONAL
2011-12-14
2013-07-25
Brief Summary
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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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KD019
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
KD019
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
Erlotinib
Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
Erlotinib
Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
Interventions
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KD019
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
Erlotinib
Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* failed one or two previous courses of therapy.
* have no active brain metastasis. Treated non-active brain metastasis are acceptable.
* cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva \[erlotinib\] or Iressa \[gefitinib\]) in the past.
* has demonstrated progressive disease.
18 Years
ALL
No
Sponsors
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Kadmon Corporation, LLC
INDUSTRY
Responsible Party
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Locations
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Yale Cancer Center
New Haven, Connecticut, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Countries
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Other Identifiers
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KD019-301
Identifier Type: -
Identifier Source: org_study_id
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