BV-NSCLC-002

• Research type

  Research Study

• Full title

  A Phase III, open-label, multicentre, randomised trial to establish safety and efficacy of an EGF cancer vaccine in inoperable, late stage IV biomarker positive, wild type EGF-R, NSCLC patients eligible to receive standard treatment and supportive care.

• IRAS ID

  152112

• Contact name

  Marianne Nicolson

• Contact email

  mnicolson@nhs.net

• Sponsor organisation

  Bioven (Europe) Ltd.

• Eudract number

  2013-005335-25

• Clinicaltrials.gov Identifier

  NCT02187367

• Duration of Study in the UK

  3 years, 3 months, 1 days

• Research summary

  The trial is a multicenter, multinational, randomised, open labeled phase III study to establish the safety and efficacy of an EGF (Epidermal Growth Factor) cancer vaccine in inoperable, stage IV NSCLC patients.
  The study vaccine is postulated to activate the immune system to generate an anti-EGF antibody response. The antibodies bind to circulating EGF and thereby prevent binding to EGF-R and subsequent activation, inhibiting the downstream signalling pathways. This vaccine-based strategy has been shown to complement chemotherapy in prolonging survival of Stage IV NSCLC patients in Phase I and II clinical trials and has received marketing authorisation in Cuba and Peru for treatment of advanced NSCLC (see chapters 5 and 6 of the Investigator’s brochure).
  Eligible subjects approximately 418 will be selected from approximately 65 centres in 14 countriesThis will include male or female subjects aged 18 years or older, with confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced, inoperable disease (Stage IV) excluding brain metastases; an ECOG performance status of 0 or 1; adequate bone marrow, liver and renal function; who are eligible to receive first-line chemotherapy (without concurrent radiotherapy to thorax measurable lesions or consolidation radiotherapy).
  Eligible patients with serum EGF concentration above threshold level of 250 pg/ml and wild type EGF-R will be randomised to an active vaccination group or non-vaccination group in a 1:1 ratio. Patients randomised to the non-vaccination arm will be treated as per the normal standard of care.
  The vaccination group will in addition to the standard of care chemotherapy receive injections with the EGF cancer vaccine at 2 time points prior to the start of the chemotherapy, at the beginning of their 2nd and 3rd chemotherapy cycle. Then in 8­weekly intervals until the disease progresses. Thereafter patients will enter a follow up phase and will not receive further study vaccine.

• REC name

  West of Scotland REC 1

• REC reference

  15/WS/0115

• Date of REC Opinion

  8 Jun 2015

• REC opinion

  Favourable Opinion