Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer

Sponsor
The Norwegian Lung Cancer Study Group
Study ID
NCT00737867
Phase
PHASE3
Status
Completed

Conditions

  • Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Vinorelbine — DRUG
    Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
  • Gemcitabine — DRUG
    Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
  • Vinorelbine — DRUG
    Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
  • Carboplatin — DRUG
    Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)

Study Details

The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.

Key Dates

Start date
Sep 30, 2007
Status verified
Apr 2011
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
444 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 All patients will receive a maximum of 3 courses with an interval of 3 weeks
  • Active Comparator: B
    Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Carboplatin infusion AUC = 5 (Calvert's formula) Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 All patients will receive a maximum of 3 courses with an interval of 3 weeks

Primary Outcome Measure

survival [ Time Frame: one year ]

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