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Clinical Trials/NCT00801736
NCT00801736
Terminated
Phase 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 enrollmentOctober 2009

Overview

Phase
Phase 3
Intervention
Cisplatin, Paclitaxel
Conditions
Lung Cancer
Sponsor
University College, London
Enrollment
648
Locations
1
Primary Endpoint
Overall Survival
Status
Terminated
Last Updated
12 years ago

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 * To examine progression-free survival, response rate and quality of life between the two treatment regimens, according to ERCC1 status. * To investigate whether the treatment effect differs according to histology (squamous vs. nonsquamous);gender (males vs. females); performance status * To undertake a cost-effectiveness analysis based on all patients, and according to ERCC1 status.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Platinum Arm

Cisplatin (IMP) / Pemetrexed (IMP)

Intervention: Cisplatin, Paclitaxel

Non Platinum Arm

Paclitaxel (IMP) / Pemetrexed (IMP)

Intervention: Cisplatin, Paclitaxel

Outcomes

Primary Outcomes

Overall Survival

Time Frame: Dec 2014

Secondary Outcomes

  • Time to progression(Dec 2014)

Study Sites (1)

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