5426W-13 GSK PEARL

CRC 13048: 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

Type of Study
Cancer (Oncology) - Lung
Swedish Cancer Institute - First Hill
Short Description

Purpose: The purpose of this study is to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer. The study will evaluate whether the PRAME immunotherapy lowers the risks of tumor recurrence after surgery.

Open to Enrollment
Principal Investigator
Eric Vallieres, M.D.
Eligibility Notes
  • Radically resected NSCLC
  • NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC. The surgical technique for resection of the patient's tumor is anatomical, involving at least a segmentectomy. The patient's tumor shows expression of PRAME
  • Must be free of disease (no residual tumor, no loco-regional recurrence, no distant metastasis), as confirmed by a post- thoracic surgery contrast-enhanced computed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhanced CT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should be performed as clinically indicated
  • ECOG performance status of 0, 1 or 2
  • No prior anti-cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy, chemotherapy or neo-adjuvant chemotherapy, except for:
    • Administration of adjuvant platinum-based doublet chemotherapy for the treatment of the current NSCLC allowed between surgery and randomization.
    • Treatment of previous malignancies as allowed by the protocol
  • No chronic long term oxygen therapy (LTOT). The patient has medically uncontrolled congestive heart failure or hypertension, unstable heart disease or uncontrolled arrhythmia at the time of randomization
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086