Overview

Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

Summary

This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small cell lung cancer (NSCLC). The primary objective is to compare progression-free survival in both arms, the secondary is to evaluate the response rate, overall survival in both arms, to evaluate the safety profile in both arms and to assess quality of life by the LCSS questionnaire.

Phase:

Phase 3

Details

Lead Sponsor:

Pierre Fabre Medicament

Collaborator:

Pierre Fabre Pharma GmbH

Treatments:

Cisplatin
Vinblastine
Vinorelbine