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.
PRIMARY OBJECTIVES:
I. To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies.
II. To access the molecular profile of blood, bronchial and nasal brushes, and bronchial
biopsies to identify molecular markers associated with treatment and response.
III. To establish the safety of recombinant human EGF-rP64K/montanide ISA 51 vaccine
(CIMAvax-EGF) treatment in cancer-free individuals using the Cancer Therapy Evaluation
Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE version 5).
SECONDARY OBJECTIVE:
I. To evaluate quality of life score changes using European Organization for the Research and
Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30) in patients who
are at high risk for development of lung cancer or recurrence during CIMAvax-EGF treatment.
OUTLINE:
LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine
intramuscularly (IM) at 0, 2, 4 and 6 weeks in the absence of disease progression or
unacceptable toxicity.
MAINTENANCE PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM
once every 4 weeks (Q4W) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 60 days.
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 =< ten years ago or be a current smoker
- Must have at least 50 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)
- Completion of adjuvant therapy after surgery at least 3 months prior to enrollment for
lung cancer
- Confirmed non-small cell lung cancer (NSCLC) stage IB 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
