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Carcinoma, Non-Small-Cell LungPhase 3EGFNCT02187367

Safety & Efficacy Study of EGF Cancer Vaccine to Treat Stage IV Biomarker Positive, Wild Type EGF-R NSCLC Patients

A Phase 3 study testing EGF Vaccine in people with Carcinoma, Non-Small-Cell Lung, run by Bioven Europe at 51 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
EGF Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
51 sitesin 11 countries
Study dates
May 2015to 6 Sep 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are aged 18 or older.
  • Have serum EGF concentration >250 pg/ml determined from sample taken at screening.
  • Have wild type EGF-R sequence.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Have adequate bone marrow, liver and renal function, as assessed by the Investigator. A sample taken at Screening should confirm that:
  • White blood cell (WBC) count ≥ 3000 per µL
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  • Platelet count ≥ 100,000 per µL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN when liver metastases are present)
  • Total bilirubin ≤ 1.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN
  • Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced inoperable disease (Stage IV [as defined by the American Joint Committee on Cancer staging system- TNM 7th edition 2010]) excluding brain metastases.
  • Are eligible to receive first-line chemotherapy (without concurrent radiotherapy to thorax measurable lesions or consolidation radiotherapy).
  • Agree to use double-barrier contraception (males and females alike [if applicable]). A negative pregnancy test must be documented at Screening for females of childbearing potential.
  • Note: Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile, while post-menopausal refers to those women with at least 2 years from last menstruation.
  • Have signed a voluntary written informed consent form (ICF). Patients should be cooperative, willing and able to participate and adhere to the Protocol requirements, including their availability for the follow-up.

Who cannot join

  • Patient has no measurable disease (as defined by RECIST Criteria, version 1.1).
  • Patient has EGF-R mutation.
  • Patient has EGF serum concentration below required threshold.
  • Patient is a candidate for concurrent chemo-radiotherapy or post chemo thoracic radiotherapy.
  • Patient has a history of known or suspected central nervous system (CNS) metastases.
  • Patient has a history of primary malignancy (except resected non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix), unless in complete remission and off all chemotherapy and/or radiotherapy for that disease for a minimum of 5 years. Any palliative radiotherapy to alleviate pain in bone metastases is permitted.
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  • Patient is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc. Use is not permitted within 1 month before Screening.
  • Patient is taking any other immunotherapy.
  • Patient has primary or secondary immunodeficiencies (e.g. documented Human Immunodeficiency Virus [HIV]).
  • Patient has autoimmune disease.
  • Patient has undergone splenectomy.
  • Patient is taking oral, intramuscular or intravenous corticosteroids. Use is not permitted within 1 month before Screening. Inhaled corticosteroids to treat respiratory insufficiency (e.g. chronic obstructive pulmonary disease [COPD]), or topical steroids are permitted.
  • Patient has neurotoxicity (Grade ≥2).
  • Patient has diarrhoea (Grade ≥2).
  • Patient has received other vaccines (with the exception of the influenza vaccine), within 1 month before Screening.
  • Patient has a history of any severe or life-threatening hypersensitivity reaction.
  • Patient has an unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease).
  • Patient has recent history (within 6 months before Screening) of chronic alcohol or drug abuse which may compromise the patient's safety or ability to participate in study activities.
  • Patient has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions.
  • Patient is currently enrolled in an investigational device or drug trial, or <1 month since completing an investigational device or drug trial.
  • Female patients who are pregnant or lactating.
  • Patient has any other factor that in the opinion of the Investigator (or designee) would make the patient unsafe or unsuitable for the study.

Trial locations and contacts

51 sites in 11 countries.

51 sites in 11 countries

Germany9 sites

  • Augusta-Kranken-Anstalt Bochum

    Bochum

  • Kliniken der Stadt Köln GmbH

    Cologne

  • Universitätsklinikum Halle (Saale) Klinik und Poliklinik fuer Innere Medizin

    Halle, Saale

  • KRH Klinikum Siloah Hannover - Oststadt

    Hanover

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    Kiel

  • Universitätsklinikum Leipzig - AöR

    Leipzig

  • LMU-München

    München

  • Mühlen-Apotheke

    Oststeinbek

Other trials in Germany

Georgia8 sites

  • Cancer Center of Adjara

    Batumi

  • Clinic Health House

    Tbilisi

  • Institute of Clinical Oncology

    Tbilisi

  • JSC, Maritime Hospital

    Tbilisi

  • JSC, Neo Medi

    Tbilisi

  • LTD, High Technology Medical Centre, University Clinic

    Tbilisi

  • LTD, Medulla - Chemotherapy and Immunotherapy Clinic

    Tbilisi

  • Research Institute Of Clinical Medicine

    Tbilisi

Other trials in Georgia

Philippines7 sites

  • Davao Doctors hospital

    Davao City

  • Perpetual Succour Hospital

    Lahug, Cebu City

  • Makati Medical Center

    Makati, Manila

  • Cancer Research Center

    Manila

  • Philippine General Hospital

    Manila

  • The Medical City

    Pasig, National Capital Region

  • Lung Center of the Philippines

    Quezon City, National Capital Region

Other trials in Philippines

Spain5 sites

  • Hospital Universitario Quiron Dexeus

    Barcelona

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario Fundación Jimenez Díaz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Regional Universitario de Málaga

    Málaga

Other trials in Spain

Thailand5 sites

  • Bangkok Hospital Chiang Mai

    Bangkok

  • Songklanagarind Hospital

    Hat Yai, Changwat Songkhla

  • Lampang Cancer Hospital

    Lampang

  • Lopburi Cancer Hospital

    Mueang, Changwat Lop Buri

  • Buddhachinaraj Hospital

    Phitsanulok

Other trials in Thailand

Malaysia4 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah

  • Sarawak General Hospital

    Kuching

  • Mahkota Medical Center

    Malacca

  • Hospital Pulau Pinang

    Pulau Pinang

Other trials in Malaysia

Czechia3 sites

  • Nemocnice Na Pleši s.r.o. Oddelení klinické onkologie a radioterapie

    Nová Ves pod Pleší

  • Pardubická krajská nemocnice, a.s.c

    Pardubice

  • Thomayerova nemocnice

    Prague

Other trials in Czechia

Romania3 sites

  • Centrul de Oncologie "Sf. Nectarie"

    Craiova

  • S.C. R.T.C. Radiology Therapeutic Center S.R.L.

    Otopeni

  • SC Oncomed SRL

    Târgu Mureş

Other trials in Romania

United Kingdom3 sites

  • Aberdeen Royal Infirmary

    Aberdeen

  • Nottingham University Hospitals

    Nottingham

  • University Hospital Southampton NHS Trust

    Southampton

Other trials in United Kingdom

Bulgaria2 sites

  • "Multiprofile Hospital for Active Treatment (MHAT)-Dobrich" AD

    Dobrich

  • MHAT for Women's Health-Nadezhda"OOD

    Sofia

Other trials in Bulgaria

Poland2 sites

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

    Olsztyn

  • Szpital Specjalistyczny w Prabutach

    Prabuty

Other trials in Poland

About this study

Official title: Phase 3 Open-label, Multicentre, Randomised Trial to Establish Safety & Efficacy of an EGF Cancer Vaccine in Inoperable, Stage IV Biomarker Positive,Wild Type EGF-R NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care

The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase 3 trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type EGF-Receptor compared to standard treatment and supportive care.

Being tested
EGF Vaccine
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EGF VaccineBiological

    Also called Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51

    1.2mL of conjugate-adjuvant mix injection at four sites during the Post First-Line Chemotherapy. Reduced dose of injection at two sites during the Pre-Progression Phase.

Study groups in NCT02187367
Study groupRoleWhat they receive
EGF VaccineExperimentalPatients in this arm will receive a low dose of cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51
Receives: Biological: EGF Vaccine
Best Supportive CareNo interventionPatients in this arm will receive best supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    To assess overall survival (OS) of an EGF cancer vaccine in inoperable, stage IV biomarker positive, wild type EGF-R, NSCLC patients compared to the control group receiving best treatment and supportive care. OS is defined as the time from randomisation to death due to any cause.

    Measured: Each patient will be followed till death occurs within study time frame of 3 years

Secondary outcomes (9)

  1. Safety of EGF Cancer Vaccine as assessed by Adverse Events (AEs)

    To assess the frequency and number of patients develop AEs, related AEs, serious AEs (SAEs) and AEs leading to withdrawal or death

    Measured: Each patient will be followed till death occurs within study time frame of 3 years

  2. Progression-Free Survival (PFS)

    Progression parameters include radiological or clinical progression, withdrawal due to progression, and death due to any cause.

    Measured: Each patient will be followed till objective tumour progression or death (whichever occurs first) within time frame of study of 3 years

  3. Survival Rate

    To assess the percentage of patients that are alive at 12 months and 24 months in EGF cancer vaccine study group compared to control group.

    Measured: Each patient will be followed at 12 and 24 months after randomization

  4. Time to Progression (TTP)

    To assess Time to Progression (TTP) from the time of randomisation to first documented disease progression of EGF cancer vaccine study group patients compared to control group.

    Measured: Each patient will be followed till observed tumour progression within study time frame of 3 years

  5. Response Rate (RECIST criteria)

    To assess the percentage of patients with a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria Version 1.1.

    Measured: Each patients will be followed till death occurs within study time frame of 3 years

  6. Safety of EGF Cancer Vaccine by Laboratory Assessment

    To assess haematology, biochemistry and urinalysis parameters

    Measured: Each patients will be followed till death occurs within study time frame of 3 years

  7. Safety of EGF Cancer Vaccine assessed by Vital Signs

    To assess systolic and diastolic blood pressure, body temperature and pulse rate

    Measured: Each patients will be followed till death occurs within study time frame of 3 years

  8. Safety of EGF Cancer Vaccine as assessed by Physical Examination

    To assess eyes, neurological and cardiovascular systems, lungs, abdomen, and any other areas with signs and symptoms of disease, and of the head, neck, ears, nose, mouth, throat, thyroid, lymph nodes and extremities

    Measured: Each patient will be followed till death occurs within study time frame of 3 years

  9. Quality of Life (QoL)

    To assess the general physical health of patients with a 36-item, short-form health survey until disease progression

    Measured: Each patient will be followed till death occurs within study time frame of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2014 (estimated)
  2. Study startMay 2015
  3. Primary completion1 May 2019
  4. Study completion6 Sep 2019

Why it stopped: Sponsor decision based on slow recruitment and new emerging drug combinations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02187367
Sponsor's protocol ID
BV-NSCLC-002
Other IDs
2013-005335-25
Acronym
EGF
Status last verified
Sep 2019
First submitted
7 Jul 2014
Last updated
10 Sep 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EGF Vaccine in people with Carcinoma, Non-Small-Cell Lung, run by Bioven Europe at 51 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Germany, Georgia, Philippines, Spain, Thailand and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision based on slow recruitment and new emerging drug combinations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Each patient will be followed till death occurs within study time frame of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187367.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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