IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer

Sponsor
Hospices Civils de Lyon
Study ID
NCT00300586
Phase
PHASE3
Status
Completed

Conditions

  • Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • observation — DRUG
    observation, second line chemotherapy if progression
  • gemcitabine — DRUG
    1250 mg/m² D1, D8 q21 days
  • erlotinib — DRUG
    150 mg daily

Study Details

The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival : * Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity. * Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.

Key Dates

First listed
Mar 9, 2006
Start date
Jun 30, 2006
Status verified
Dec 2011
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

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

Arms

  • Sham Comparator: A (supervision)
    medical supervision, second line chemotherapy if progression
  • Active Comparator: B (gemcitabicine)
    Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression
  • Experimental: C (Erlotinib)
    Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression

Primary Outcome Measure

Progression free survival since randomization [ Time Frame: time until progression ]

Related Studies