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KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01487174
Recruitment Status : Terminated (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)
First Posted : December 7, 2011
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Tracking Information
First Submitted Date  ICMJE December 2, 2011
First Posted Date  ICMJE December 7, 2011
Last Update Posted Date July 24, 2014
Study Start Date  ICMJE November 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
Overall survival [ Time Frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
  • Progression-free survival [ Time Frame: 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 [ Time Frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year ]
    For the purpose of data collection, all untoward events that occur after informed consent through 30 days after last dose of study treatment are to be recorded.
  • Objective response rate [ Time Frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: KD019
    KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
    Other Name: XL647
  • Drug: 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 Name: Tarceva
Study Arms  ICMJE
  • Experimental: KD019
    KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
    Intervention: Drug: KD019
  • Active Comparator: Erlotinib
    Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
    Intervention: Drug: Erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 6, 2014)
8
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2011)
620
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For Eligibility subjects must have:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01487174
Other Study ID Numbers  ICMJE KD019-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kadmon Corporation, LLC
Study Sponsor  ICMJE Kadmon Corporation, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kadmon Corporation, LLC
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP