A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence
NCT04298606 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-03-17
Summary
This early phase I trial studies the side effects of a vaccine called CIMAvax-EGF and to see how well it works in preventing lung cancer from developing in patients at high risk for lung cancer or coming back (recurrence) in stage IB-IIIA non-small cell lung cancer survivors. In many cancers such as lung cancer, there is a protein receptor called EGFR (epidermal growth factor receptor) that is overexpressed within these cancers. Activation of EGFR has shown to lead to tumor growth and development. Previous studies have indicated that EGFR activation is present in the airways of cancer-free subjects as well. CIMAvax-EGF vaccine works by causing the body to make antibodies against EGF that is being produced that could be possibly driving the risk for developing cancer.
Conditions
- Chronic Obstructive Pulmonary Disease
- Lung Non-Small Cell Carcinoma
- Pneumonia
- Stage IB Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
Interventions
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- BIOLOGICAL
-
Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Given IM
Sponsors & Collaborators
-
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Mary Reid, PhD · Roswell Park Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-22
- Primary Completion
- 2025-12-05
- Completion
- 2026-02-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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