Lung Cancer Vaccine for Lung Cancer Prevention and Recurrence

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Roswell Park Cancer Institute

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Uncontrolled illness, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using systemic immunosuppressant drugs like steroids, you must stop them at least 4 weeks before joining the study.

What data supports the effectiveness of the lung cancer vaccine treatment for lung cancer prevention and recurrence?

Research shows that the EGF-based vaccine, similar to the one being studied, has been effective in advanced non-small-cell lung cancer (NSCLC) by inducing an immune response that helps block cancer growth signals. Patients who developed a strong immune response to the vaccine lived longer than those who did not. ^{1 2 3 4 5}

Is the lung cancer vaccine safe for humans?

The lung cancer vaccine, also known as CIMAvax-EGF or Hu-rhEGF-rP64k/Mont, has been tested in several clinical trials and is generally considered safe for humans. Common side effects include mild reactions at the injection site, fever, headache, and vomiting, but no significant toxicity has been reported. ^{1 2 4 6 7}

How does the lung cancer vaccine differ from other treatments for lung cancer?

The lung cancer vaccine, CIMAvax-EGF, is unique because it targets the epidermal growth factor (EGF), a protein that helps cancer cells grow. By inducing the body to produce antibodies against EGF, it prevents EGF from activating its receptor on cancer cells, which can slow down or stop the growth and spread of the cancer. This approach is different from traditional treatments that directly target the cancer cells themselves. ^{1 3 4 8 9}

Research Team

Mary Reid, PhD

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for high-risk individuals or stage IB-IIIA non-small cell lung cancer survivors without current evidence of cancer. Participants must have a good performance status, agree to contraception if applicable, and not be pregnant. High-risk factors include moderate/severe COPD, family history of lung cancer, low BMI, pneumonia in the last 5 years, exposure to certain substances like asbestos or radon, recent smoking history with significant pack-years.

Inclusion Criteria

I am at high risk for lung cancer due to factors like COPD, family history, low BMI, recent pneumonia, occupational exposure, or smoking history.

You must have enough platelets in your blood (at least 100 billion per liter).

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

Exclusion Criteria

It is not safe for me to undergo a bronchoscopy.

I have a condition that weakens my immune system, like HIV.

I am an adult capable of making decisions, not pregnant, and not incarcerated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Loading Phase

Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine intramuscularly at 0, 2, 4, and 6 weeks

6 weeks

4 visits (in-person)

Maintenance Phase

Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine intramuscularly once every 4 weeks

Ongoing until disease progression or unacceptable toxicity

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Treatment Details

Interventions

• Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine

Trial Overview The CIMAvax-EGF vaccine is being tested for its ability to prevent the development or recurrence of lung cancer by targeting a protein (EGFR) linked to tumor growth. The study includes questionnaires and quality-of-life assessments alongside the vaccine administration.

Participant Groups

Group I: Prevention (recombinant human EGF-rP64K/montanide ISA 51) Experimental Treatment 3 Interventions

LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine 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 Q4W in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Findings from Research

The Hu-rhEGF-rP64k/Mont vaccine for advanced non-small cell lung cancer (NSCLC) was found to be safe and well tolerated, with only mild adverse effects reported, such as dizziness and injection-site reactions, and no severe adverse events or deaths related to the vaccination.

The vaccine successfully induced an immune response, generating anti-EGF antibodies that led to a decrease in EGF concentration, and 80% of the vaccinated patients achieved stable disease, indicating potential effectiveness for further clinical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic cancer vaccine: phase I clinical tolerance study of Hu-rhEGF-rP64k/Mont in patients with newly diagnosed advanced non-small cell lung cancer. Xing, P., Wang, H., Yang, S., et al.[2019]

In a Phase I trial involving 43 patients with advanced non-small cell lung cancer, an EGF vaccine showed good immunogenicity, with 39% of patients developing a strong antibody response and no significant toxicity reported.

Patients who received the double dose of the EGF vaccine had a trend toward increased survival, and those with higher antibody titers and lower serum EGF levels experienced significantly better survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of NSCLC patients with an EGF-based cancer vaccine: report of a Phase I trial. Ramos, TC., Vinageras, EN., Ferrer, MC., et al.[2020]

CIMAvax-EGF, a therapeutic cancer vaccine targeting the epidermal growth factor receptor (EGFR), was well tolerated in advanced non-small-cell lung cancer (NSCLC) patients, with mild side effects like injection site reactions and fever.

Patients receiving at least 4 doses of CIMAvax-EGF showed a significant survival advantage, especially those with high baseline EGF levels, indicating its potential as an effective maintenance therapy after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CIMAvax EGF (EGF-P64K) vaccine for the treatment of non-small-cell lung cancer. Crombet Ramos, T., Rodríguez, PC., Neninger Vinageras, E., et al.[2019]

The EGF-based cancer vaccine was found to be safe, with adverse events occurring in less than 25% of patients, and most were mild (grade 1 or 2).

Patients who received the vaccine showed a significant increase in anti-EGF antibody responses and a decrease in serum EGF levels, which correlated with improved survival, particularly in patients younger than 60 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer. Neninger Vinageras, E., de la Torre, A., Osorio Rodríguez, M., et al.[2018]

In a pooled analysis of three pilot clinical trials involving 83 patients with advanced non-small cell lung cancer (NSCLC), the EGF vaccine was found to be safe and elicited specific anti-EGF antibody responses in 83% of participants, with 49% showing strong responses.

Patients who developed good antibody responses to the EGF vaccine had significantly longer survival rates compared to those with poor responses, suggesting a potential link between immunogenicity and improved survival outcomes, even though these trials were not designed to confirm therapeutic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic vaccination with epidermal growth factor (EGF) in advanced lung cancer: analysis of pooled data from three clinical trials. González, G., Crombet, T., Neninger, E., et al.[2019]

CIMAvax-EGF, a vaccine designed to induce antibodies against epidermal growth factor (EGF), has been shown to be safe and immunogenic in patients with advanced non-small cell lung cancer (NSCLC), based on a Phase III trial involving 405 patients.

The vaccine significantly improved overall survival in patients who received at least four doses, with high baseline EGF levels serving as a predictive biomarker for its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CIMAvax-EGF: A New Therapeutic Vaccine for Advanced Non-Small Cell Lung Cancer Patients. Saavedra, D., Crombet, T.[2019]

CimaVax-EGF, a therapeutic cancer vaccine targeting Epidermal Growth Factor (EGF), has been safely administered to over 1000 advanced non-small cell lung cancer (NSCLC) patients, showing manageable side effects like mild injection site reactions and fever.

High-dose vaccination at multiple sites led to a significant increase in antibody response and a faster decrease in circulating EGF, suggesting potential improvements in survival rates for patients classified as good responders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor (EGF) based cancer vaccine in advanced non small cell lung cancer (NSCLC) patients. Rodriguez, PC., Neninger, E., García, B., et al.[2021]

CIMAvax-EGF is a vaccine designed to target the epidermal growth factor (EGF), which plays a crucial role in the development of non-small cell lung cancer (NSCLC), and has been shown to be safe and immunogenic in patients with advanced NSCLC.

The vaccine works by inducing antibodies against EGF, leading to its withdrawal, which may contribute to improved long-term survival in a subgroup of patients with advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CIMAvax-EGF: Toward long-term survival of advanced NSCLC. Saavedra, D., Neninger, E., Rodriguez, C., et al.[2018]

CIMAvax-EGF, a therapeutic cancer vaccine for non-small cell lung cancer (NSCLC), was found to be safe with mild adverse reactions, and it successfully induced anti-EGF antibodies while decreasing serum EGF levels.

Patients with advanced NSCLC who received the vaccine showed a median survival time of 12.43 months when they completed at least four doses, compared to 9.43 months in the control group, indicating a significant survival benefit linked to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non-Small Cell Lung Cancer Patients. Rodriguez, PC., Popa, X., Martínez, O., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Therapeutic cancer vaccine: phase I clinical tolerance study of Hu-rhEGF-rP64k/Mont in patients with newly diagnosed advanced non-small cell lung cancer. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of NSCLC patients with an EGF-based cancer vaccine: report of a Phase I trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

CIMAvax EGF (EGF-P64K) vaccine for the treatment of non-small-cell lung cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Therapeutic vaccination with epidermal growth factor (EGF) in advanced lung cancer: analysis of pooled data from three clinical trials. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

CIMAvax-EGF: A New Therapeutic Vaccine for Advanced Non-Small Cell Lung Cancer Patients. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor (EGF) based cancer vaccine in advanced non small cell lung cancer (NSCLC) patients. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

CIMAvax-EGF: Toward long-term survival of advanced NSCLC. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non-Small Cell Lung Cancer Patients. [2018]