A Phase III, open-label multicentre trial in late stage NSCLC patients

• 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 (IIIb/IV) NSCLC patients eligible to receive standard treatment and supportive care.

• IRAS ID

  72886

• Contact name

  Marianne Nicolson

• Sponsor organisation

  Bioven (Europe) Ltd.

• Eudract number

  2010-020023-43

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  This is a Phase III, open-label, multicentre, randomised trial to establish safety and efficacy of an EGF (Epidermal Growth Factor) cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients eligible to receive standard treatment and supportive care. 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 IIIb/IV NSCLC patients in Phase I and II clinical trials and has received marketing authorisation in Cuba and Peru for treatment of advanced NSCLC. This study is a part of the process to receive approval from Regulatory Authorities in further countries.Eligible subjects approximately 438 will be selected from 70 centres in 11 countries (Australia, India, Thailand, Malaysia, UK, Spain, Germany, Poland, Hungary, Czech Republic, and Ukraine). This will include male or female subjects aged 20-65 years (inclusive), with proven advanced, inoperable NSCLC (Stage IIIb/IV); 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 thoracic or consolidation radiotherapy).Eligible patients will be randomised to the active vaccine group or the 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 8-weekly intervals until the disease progresses. Thereafter patients will enter a follow up phase and will not receive further study vaccine.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0472

• Date of REC Opinion

  1 Sep 2011

• REC opinion

  Further Information Favourable Opinion