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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine called CIMAvax-EGF (Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine) to determine if it can prevent lung cancer from developing or returning in individuals at high risk or those who have survived certain stages of lung cancer. The vaccine triggers the body to produce antibodies against a protein that may promote tumor growth. The trial seeks participants with risk factors such as a history of smoking or those who have had non-small cell lung cancer but are currently cancer-free. Participants must show no signs of cancer on a recent CT scan and have a history of smoking or be survivors of specific lung cancer types. As an Early Phase 1 trial, this research aims to understand how the vaccine works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the CIMAvax-EGF vaccine is generally safe for people. Studies have found that this vaccine can help the immune system combat potential cancer-causing agents. In earlier trials, most participants experienced only mild side effects, such as redness or swelling at the injection site, and occasionally flu-like symptoms. No serious side effects were reported, suggesting the vaccine is safe to use. However, since this trial remains in the early stages, more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lung cancer, which often involve surgery, chemotherapy, and radiation therapy, the recombinant human EGF-rP64K/Montanide ISA 51 vaccine represents a novel approach aiming to prevent lung cancer or its recurrence. This vaccine works by stimulating the immune system to target and attack cancer cells, offering a potentially less invasive and more targeted option. Researchers are excited about this treatment because it could reduce the need for traditional therapies and minimize side effects, making the management of lung cancer less burdensome for patients.

What evidence suggests that this vaccine might be an effective treatment for lung cancer prevention and recurrence?

Research shows that the CIMAvax-EGF vaccine targets a protein called EGF, which can promote cancer growth. The vaccine helps the body produce antibodies against this protein, potentially reducing the risk of lung cancer starting or returning. Previous studies found that patients who received this vaccine developed these beneficial antibodies without experiencing serious side effects. In this trial, participants will receive the recombinant human EGF-rP64K/montanide ISA 51 vaccine, which is being tested for its potential to prevent lung cancer in high-risk individuals. ^{1 6 7 8 9}

Who Is on the Research Team?

Mary Reid, PhD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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 have an autoimmune disorder but it's either vitiligo or an endocrine issue treated with hormones.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04298606

A Vaccine (CIMAvax-EGF) for the Prevention of Lung ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5902871/

phase I clinical tolerance study of Hu-rhEGF-rP64k/Mont in ... No severe adverse events or death were related to the vaccination. Immune monitoring demonstrated the generation of anti-EGF antibody titers and ...

3. withpower.com withpower.com/trial/early-phase-1-lung-neoplasms-2-2021-643c2

Lung Cancer Vaccine for Lung Cancer Prevention and Recurrence 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9382666/

Findings from a phase I trial of CIMAvax-EGF in ... Despite improved clinical outcomes with newer treatments, long-term 5-year survival rates remain dismal for NSCLC patients, hence the ongoing need for better ...

5. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/recombinant-human-egf-rp64k-montanide-isa-51-vaccine

Clinical Trials Using Recombinant Human EGF-rP64K/ ... Review the clinical trials studying recombinant human egf-rp64k/montanide isa 51 vaccine on this list and use the filters to refine the results by age and ...

6. trialx.com trialx.com/clinical-trials/listings/251400/a-vaccine-cimavax-egf-for-the-prevention-of-lung-cancer-development-or-recurrence/

A Vaccine (CIMAvax-EGF) for the Prevention of Lung ... To establish the safety of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax-EGF) treatment in cancer-free individuals using the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3215653/

Safety, immunogenicity and preliminary efficacy of multiple ... CimaVax-EGF is a therapeutic cancer vaccine composed by human recombinant Epidermal Growth Factor ... EGF (rEGF/rp64k/Montanide ISA 51 VG).

8. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-human-egf-rp64k-montanide-isa-51-vaccine

recombinant human EGF-rP64K/Montanide ISA 51 vaccine Recombinant human EGF-rP64K/Montanide ISA 51 vaccine may trigger a humoral immune response against vaccine rEGF and rP64K and, so, against endogenous EGF.

9. ctv.veeva.com ctv.veeva.com/study/a-vaccine-cimavax-egf-for-the-prevention-of-lung-cancer-development-or-recurrence

A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer ... 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 ...