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