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

• ClinicalTrials.gov Identifier: NCT01487174
• Recruitment Status: Terminated
• First Posted: December 7, 2011
• Last Update Posted: May 13, 2022
• Sponsor: Kadmon Corporation, LLC
• Information provided by (Responsible Party): Kadmon Corporation, LLC

Tracking Information

• First Submitted Date: December 2, 2011
• First Posted Date: December 7, 2011
• Last Update Posted Date: May 13, 2022
• Study Start Date: December 14, 2011
• Actual Primary Completion Date: July 25, 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small-Cell Lung

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 6, 2014): 8
• Original Estimated Enrollment (submitted: December 5, 2011): 620
• Actual Study Completion Date: July 25, 2013
• Actual Primary Completion Date: July 25, 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01487174
• Other Study ID Numbers: KD019-301
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kadmon Corporation, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Kadmon Corporation, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kadmon Corporation, LLC
• Verification Date: May 2022