RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 0 Study of CIMAvax-EGF Vaccine in Patients Who Are at High Risk for Lung Cancer and Lung Cancer Survivors at Risk for Recurrence

Quick Facts

Study Start:2021-11-22

Study Completion:2024-11-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04298606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Mary Reid, PhD

PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

Mary Reid, PhD, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-22

Study Completion Date2024-11-22

Study Record Updates

Study Start Date2021-11-22

Study Completion Date2024-11-22

Terms related to this study

Additional Relevant MeSH Terms

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