A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease Read More

Inclusion Criteria:

• Confirmed no evidence of cancer on computed tomography (CT) scan within 6 months prior to starting treatment
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Patients must have platelets >= 100 x 10^9/L

• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry

  • Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• PATIENTS AT HIGH-RISK FOR LUNG CANCER COHORT ONLY (COHORT A)

• Must have documented at least one risk factor for lung cancer which includes:

  • Moderate to severe chronic obstructive pulmonary disease (COPD) defined as FEV1/FVC ratio <=75%
  • Positive family history of lung cancer defined as a first degree relative
  • Low body mass index (BMI)
  • History of pneumonia within the last 5 years prior to enrollment
  • Occupational exposure such as asbestos, radon and any other that investigator would deem high risk
• Must have quit smoking =< 15 years ago or be a current smoker
• Must have at least 30 pack year smoking history
• Must have documented pulmonary function test within the last 3 years prior to enrollment. If a patient cannot tolerate a pulmonary function test, an incentive spirometry will be acceptable in place of a pulmonary function test
• LUNG CANCER SURVIVOR COHORT ONLY (COHORT B)
• 1. If patient received surgery or any adjuvant therapy for initial diagnosis of lung cancer, it must have been completed at least 3 months prior to enrollment. Prior surgery or any therapy is not required for eligibility
• Confirmed non-small cell lung cancer (NSCLC) stage IA through 3A at initial diagnosis

Exclusion Criteria:

• Clinically inappropriate to have a bronchoscopy procedure
• Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, history of clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or nursing female participants
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
• Received an investigational agent within 30 days prior to enrollment
• Has known immunosuppressive disease (e.g. human immunodeficiency virus [HIV], acquired immunodeficiency syndrome [AIDS] or other immune depressing disease). Testing is not mandatory
• Patient has known hypersensitivity to the components of the study drugs or any analogs
• History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible. Systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before recruitment

• The following special populations are excluded from this study:

  • Cognitively impaired adults/adults with impaired decision-making capacity
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners
  • Pregnant women