A study of patritumab with erlotinib in subjects with NSCLC

• Research type

  Research Study

• Full title

  Phase 3, Randomised, Placebo-Controlled, Double-blind, Multi-Centre, Two-Part Study of Patritumab (U3-1287) in Combination with Erlotinib in EGFR Wild-type Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy

• IRAS ID

  144247

• Contact name

  Martin Forster

• Contact email

  m.forster@ucl.ac.uk

• Sponsor organisation

  Daiichi Sankyo Development Limited

• Eudract number

  2013-004371-12

• Clinicaltrials.gov Identifier

  NCT02134015

• Research summary

  Patritumab is a monoclonal antibody which is made in the laboratory to target specific protein found on cancer.

  Patritumab in combination with erlotinib is being studied as treatment for locally advanced or metastatic (spread of cancer) non-small cell lung cancer (NSCLC) after progression on at least one prior systemic therapy (Relating to or affecting the entire body or an entire organism). It is hypothesised that high levels of heregulin most likely will predict the efficacy of this combination.

  This is a 2 part multicentre, randomised, placebo-controlled, double-blind study; neither the participant nor the study doctor will know which medication is being given.

  The aims of Part A (approximately 180 participants) are:
  1) to confirm that the combination of patritumab with erlotinib will improve progression free survival in NSCLC participants who have progressed on prior systemic therapy- particularly participants with high levels of heregulin expression as determined by an investigational test.
  2) to refine the cut-off for the definition of heregulin high lung cancers.

  The aim of part B (approximately 600 patients) is to determine if the combination patritumab+ erlotinib improves overall survival in participants with locally advanced or metastatic NSCLC who have progressed on prior systemic therapy and have high level of heregulin. A new definition of heregulin-high will be created in part A and will be used to determine which participants are eligible for Part B.

  This study will enrol across Europe, US, Canada, Brazil, Asia and Australia. An independent Data Monitoring Committee will review the efficacy and safety from Part A and will make a recommendation to the sponsor whether or not to proceed with Part B.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  14/SC/1167

• Date of REC Opinion

  27 Oct 2014

• REC opinion

  Further Information Favourable Opinion