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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

This study is currently recruiting participants.
Verified November 2012 by Kadmon Corporation, LLC
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC
ClinicalTrials.gov Identifier:
NCT01487174
First received: December 2, 2011
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
 Drug: KD019
Drug: Erlotinib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 620
Study Start Date: November 2011
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KD019
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
 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
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.
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 EGFR inhibitor (Tarceva[erlotinib] or Iressa[gefitinib]) in the past.
  • has demonstrated progressive disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487174

Locations
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: BrieAnna Hamel, CCRP     203-737-4778     BrieAnna.Hamel@yale.edu    
United States, New Mexico
San Juan Oncology Associates Recruiting
Farmington, New Mexico, United States, 87401
Contact: Rosemarie Mestas         rosemarie@sjonc.com    
Sponsors and Collaborators
Kadmon Corporation, LLC
  More Information

No publications provided

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT01487174     History of Changes
Other Study ID Numbers: KD019-301
Study First Received: December 2, 2011
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013