A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT01196078
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib [Tarceva] — DRUG
    150 mg, orally once a day for up to 6 cycles of 21 days each
  • vinorelbine — DRUG
    60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles

Study Details

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.

Key Dates

Start date
Feb 28, 2007
Status verified
Jun 2015
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year ]

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