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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

KD019-301

NCT ID:

NCT01487174

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Yale Cancer Center New Haven, Connecticut  06520-8028
San Juan Oncology Associates Farmington, New Mexico  87401