ERCC1 Targeted Trial

Phase 3

Terminated

• Conditions: Lung Cancer
• Interventions: Drug: Cisplatin, Paclitaxel

• Registration Number: NCT00801736
• Lead Sponsor: University College, London

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.

Study Timeline

• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Study Start: 2009-10
• Status Verified: 2012-12
• Primary Completion: 2013-07
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 648

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platinum Arm	Cisplatin, Paclitaxel	Cisplatin (IMP) / Pemetrexed (IMP)
Non Platinum Arm	Cisplatin, Paclitaxel	Paclitaxel (IMP) / Pemetrexed (IMP)

Primary Outcome Measures

Name	Time	Method
Overall Survival	Dec 2014

Secondary Outcome Measures

Name	Time	Method
Time to progression	Dec 2014

Trial Locations

Locations (1)

University College London Hospitals; 🇬🇧 London, United Kingdom