EMR 63325-021 Phase 3 Trial of Tecemotide in NSCLC

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, placebo-controlled phase III trial of tecemotide versus placebo in subjects with completed concurrent chemo-radiotherapy for unresectable stage III non-small cell lung cancer (NSCLC)

• IRAS ID

  144769

• Contact name

  Mary O'Brien

• Contact email

  mary.o'brien@rmh.nhs.uk

• Sponsor organisation

  Merck KGaA

• Eudract number

  2013-003760-30

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a multi-centre study in patients with stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery (i.e. unresectable). Participants will be placed at random (by chance) into one of two treatment arms with a 50% chance of being in either arm.

  One arm will receive tecemotide and the other will receive placebo. Neither the participant nor the study doctor will know which treatment arm they are in.

  An estimated 1002 subjects (501 in each treatment arm) will be enrolled globally.

  Participants will receive subcutaneous (s.c. – under the skin) injections of either tecemotide or placebo weekly for eight consecutive weeks followed by s.c. injections every 6 weeks and continuing until their disease worsens, toxicity, or at the discretion of investigator or they withdraw consent.

  The aim of the study is to compare Overall Survival time for each treatment arm.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  14/LO/0247

• Date of REC Opinion

  28 Apr 2014

• REC opinion

  Further Information Favourable Opinion