NCT00300586

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

A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 842 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stage IV Non-small Cell Lung Cancer

Interventions

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

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2006-03-09
• Last updated: 2019-05-28

Locations

1 site across 1 country: France