This clinical trial will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin

Official Title

A Phase II/III Randomized, Double-Blind Study of Paclitaxel Plus Carboplatin in Combination With Vorinostat or Placebo in Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)


Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer

Study Type


Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

  • Primary Outcome Measures: Overall survival
  • Secondary Outcome Measures: Progression Free Survival and Response Rate

Study Start

May 2007

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Males and females at least 18 years of age who have confirmed diagnosis of Non-small Cell Lung Cancer
  • Patients with no prior treatment for lung cancer except patients at least 12 months from prior adjuvant therapy
  • Adequate bone marrow,kidney and liver function.
  • Must be recovered and at least 4 weeks from major surgery or radiation treatment
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
  • Men and women must agree to use birth control during the study
  • Women able to have children must have a negative pregnancy test 14 days before study enrollment

Exclusion Criteria:

  • Patients with prior treatment with other investigational agents less than 4 weeks before study enrollment
  • Pregnant or nursing female patients.
  • Patients who are HIV positive
  • Patients who have Hepatitis A, B, or C
  • Patients unable to take study medication by mouth
  • Patients with untreated brain cancer
  • Patient eligible for treatment with bevacizamab

Total Enrolment


Contact Details

  • Merck Sharp & Dohme (Australia) Inc., South Granville, NSW 2142, Australia; Recruiting

David Woolner: 61-2-9795-9500

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