PEARL-PRAME as Adjuvant Immunotherapy in Resected NSCLC
Research type
Research Study
Full title
A double blind, randomized, placebo controlled phase II study to assess the efficacy of recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resected PRAME-positive, Non-Small Cell Lung Cancer
IRAS ID
119289
Contact name
Paul David Taylor
Contact email
Sponsor organisation
GlaxoSmithKline UK Ltd
Eudract number
2012-002790-55
Research summary
This research study will test a new treatment for NSCLC to determine whether the investigational treatment works to delay or prevent the lung cancer from coming back after surgery and how safe it is. Currently, chemotherapy is offered to most NSCLC patients who have had surgery, however, receiving chemotherapy does not always stop the lung cancer from coming back in the future. Also, not all NSCLC patients who have had surgery are able to receive chemotherapy. There is a need to identify new post-surgery treatments for NSCLC patients to improve their outcomes.
The investigational cancer treatment is called an antigen-specific cancer immunotherapeutic (ASCI). It is believed that the ASCI may work by educating a patient’s own immune system to fight the cancer cells that display a particular antigen (a substance in the body that causes an antibody).
In order to be able to participate in this research study, patients will have had surgery for NSCLC (Stage 1A-T1b, IB, II or IIIA). The patients’ tumour will then be checked for the specific antigen before being considered for study entry. Only two thirds of patients with NSCLC will have tumours that produce the specific antigen.
Worldwide, 220 patients will be recruited. Patients will have two chances out of three to receive the ASCI and one chance out of three to receive a dummy injection. Patients will receive 13 injections over a period of just over 2 years and will then be followed up for a further 3 years. The patient will have regular CT scans to check for the lung cancer coming back.
The pharmaceutical company who is developing the ASCI is funding the study.
Five hospitals in the UK will be participating in the study, recruiting 20 patients.
REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0215
Date of REC Opinion
20 May 2013
REC opinion
Further Information Favourable Opinion