ERCC1 Targeted Trial (ET)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall Survival [ Time Frame: Dec 2014 ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Dec 2014 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Platinum Arm
Cisplatin (IMP) / Pemetrexed (IMP) - Non-squamous or Cisplatin (IMP) / Gemcitabine (IMP) - Squamous
Drug: Cisplatin, Paclitaxel
Experimental: Non Platinum Arm
Paclitaxel (IMP) / Pemetrexed (IMP) - Non-squamous or Paclitaxel (IMP) / Gemcitabine (IMP) - Squamous
Drug: Cisplatin, Paclitaxel
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.
- 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.
|Contact: Hassan Khan, Bsc(Hons)||0207 679 firstname.lastname@example.org|
|University College London Hospitals||Recruiting|
|London, United Kingdom|
|Contact: Siow M Lee|
|Principal Investigator:||Siow M. Lee, MD, PhD, FRCP||Cancer Research UK|