H3E-EW-S124: Maintenance Pemetrexed plus BSC vs BSC alone in ns-NSCLC

• Research type

  Research Study

• Full title

  A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Nonsquamous Non Small Cell Lung Cancer

• Sponsor organisation

  Eli Lilly Company Ltd

• Eudract number

  2008-002155-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Lung cancer is one of the leading causes of cancer??related deaths in industrialised countries, with non??small cell lung cancer (NSCLC) accounting for the majority of cases. NSCLC covers three main different histology types, that is, tumour types differentiated by the structure of their cells; squamous cell carcinoma, adenocarcinoma and large cell carcinoma. This study does not include patients with mainly squamous histology.Four cycles of combination chemotherapy are considered optimal initial treatment for patients with advanced??stage NSCLC. Patients whose disease responds or stabilises after initial chemotherapy could benefit from receiving single agent maintenance therapy when the tumour burden is low. Maintenance therapy could potentially provide a further increase in overall survival rates, slow disease progression and improve quality of life with minimal side effects.This double-blind study of approximately 600 patients is designed to compare maintenance therapy with pemetrexed plus best supportive care (BSC) versus placebo plus BSC, in terms of objective progression free survival (the time to first worsening of disease or death) in patients with advanced non??squamous NSCLC who have not progressed (got worse) during 4 cycles of pemetrexed cisplatin induction (1st line) chemotherapy. All patients on this study will receive 4 intravenous infusions of each of the chemotherapy drugs pemetrexed and cisplatin (approximately every 3 weeks). Patients who complete 4 such cycles and respond well to their treatment will be randomized to receive either pemetrexed or placebo (approximately every 3 weeks), with twice the likelihood of receiving pemetrexed than placebo. Treatment will last until inadequate response (progressive disease or administration of alternative treatment), adverse event, non-compliance, subject or sponsor decision to terminate. Following this, patients will have one 30 day post discontinuation visit, and will then be followed every 6 weeks until disease progression if indicated then every 90 days until study closure or death.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  08/H0505/143

• Date of REC Opinion

  9 Oct 2008

• REC opinion

  Further Information Favourable Opinion