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NCT04298606CompletedEarly phase 1

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

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

Source: ClinicalTrials.gov · Last updated 17 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
20 (actual)
First submitted
4 Mar 2020
Start date
22 Nov 2021
Primary completion date
5 Dec 2025
Lead sponsor
Roswell Park Cancer Institute
Diseases
COPD, Lung cancer
NCT number
NCT04298606

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 20
  • From 22 Nov 2021 to the primary completion date, 5 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received an investigational agent within 30 days prior to enrollment
  • 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

Other illness

  • 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
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
  • 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

Other

  • Clinically inappropriate to have a bronchoscopy procedure
  • Pregnant or nursing female participants
  • Unwilling or unable to follow protocol requirements
  • 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

Who the study is looking for

  • 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

Age in the registry: 50 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.