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Clinical Trials/NCT00801736
NCT00801736TerminatedPhase 3

A Multicentre, Randomised, Phase III Trial of Platinum-based Chemotherapy Versus Non-platinum Chemotherapy, After ERCC1 Stratification, in Patients With Advanced/Metastatic Non-small Cell Lung Cancer

University College, London1 site in 1 country648 target enrollmentStarted: October 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
648
Locations
1
Primary Endpoint
Overall Survival

Study Overview

Brief Summary

Lung cancer is the leading cause of cancer death in the UK, leading to 34 000 deaths each year (22% of cancer deaths). Non-small cell lung cancer (NSCLC) is the most common histology, accounting for approximately 80% of cases and most present with advanced, stage IIIb or IV disease. The recommended treatment for advanced disease is a doublet platinum-based chemotherapy, although the survival benefits are modest. Even among those fit enough for chemotherapy, the response rate is only 20-40%, and median survival averages 9-10 months with the newer platinum-containing chemotherapy regimen (Schiller et al, 2002; Rudd et al, 2005; Lee et al, 2007). Only 11% of patients went on to survive 2 years when treated with the newer gemcitabine/carboplatin regimen established by the London Lung Cancer Group (Rudd et al, 2005; Lee et al, 2007). New strategies are needed to further improve the prognosis of this disease.

Detailed Description

TRIAL OBJECTIVES

Primary objective

The trial will have two main objectives:

  • To detect an improvement in survival for ERCC1+ve patients treated with a non-platinum chemotherapy compared to platinum-based treatment.
  • To establish non-inferiority or improvement in survival for ERCC1-ve patients treated with a platinum-based chemotherapy compared to non-platinum treatment.

Secondary objectives

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Platinum Arm

Experimental

Cisplatin (IMP) / Pemetrexed (IMP)

Intervention: Cisplatin, Paclitaxel (Drug)

Non Platinum Arm

Experimental

Paclitaxel (IMP) / Pemetrexed (IMP)

Intervention: Cisplatin, Paclitaxel (Drug)

Outcomes

Primary Outcomes

Overall Survival

Time Frame: Dec 2014

Secondary Outcomes

  • Time to progression(Dec 2014)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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