Study Stopped
Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues
KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy
A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
1 other identifier
interventional
8
1 country
2
Brief Summary
This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedStudy Start
First participant enrolled
December 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2013
CompletedMay 13, 2022
May 1, 2022
1.6 years
December 2, 2011
May 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Secondary Outcomes (3)
Progression-free survival
Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Number and type of adverse events related to KD019
Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Objective response rate
Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Study Arms (2)
KD019
EXPERIMENTALKD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
Erlotinib
ACTIVE COMPARATORErlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
Interventions
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (2)
Yale Cancer Center
New Haven, Connecticut, 06519, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2011
First Posted
December 7, 2011
Study Start
December 14, 2011
Primary Completion
July 25, 2013
Study Completion
July 25, 2013
Last Updated
May 13, 2022
Record last verified: 2022-05