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

Launched by ROSWELL PARK CANCER INSTITUTE · Mar 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a vaccine called CIMAvax-EGF, which aims to prevent lung cancer from developing or coming back in patients who are at high risk. The vaccine works by helping the body produce antibodies against a protein that can promote tumor growth. It's specifically looking at individuals with chronic obstructive pulmonary disease (COPD) or those who have survived early-stage non-small cell lung cancer. The goal is to see how effective this vaccine is in preventing cancer in these groups.

To participate in this trial, you need to be an adult who has no signs of cancer on a recent scan and meets certain health criteria. For example, you should have a history of smoking or specific risk factors for lung cancer, like having COPD or a family history of lung cancer. Participants will receive the vaccine and will be monitored for any side effects and how well the vaccine is working. It’s important to know that this study is recruiting now, and you would need to provide informed consent before starting. If you have any questions or think you might qualify, it's a good idea to talk to your doctor.

Gender

ALL

Eligibility criteria

• 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