Carcinoma, Non-Small-Cell LungPhase 3NSCLCNCT01444118

A Randomized Trial to Study the Safety and Efficacy of EGF Cancer Vaccination in Late-stage (IIIB/IV) Non-small Cell Lung Cancer Patients

A Phase 3 study testing Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine) in people with Carcinoma, Non-Small-Cell Lung, run by Bioven Europe at 1 site in United Kingdom.

Terminated

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

Official record

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Trial summary

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: Not given
Where: 1 siteUnited Kingdom
Study dates: Nov 2011to Dec 2014
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 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are aged 20-65 years (inclusive).
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
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)

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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 IIIb or Stage IV [as defined by the American Joint Committee on Cancer staging system]), excluding brain metastases.
Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy 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 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.
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.

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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 a 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

1 site in 1 country.

United Kingdom1 site

Aberdeen Royal Infirmary
Aberdeen

Other trials in United Kingdom

About this study

Official title: Phase III, Open-label, Multicentre, Randomised Trial to Establish Safety and Efficacy of an EGF Cancer Vaccine in Inoperable, Late Stage (IIIb/IV) NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care.

The vaccine contains humanized recombinant antigen (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 III 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 III trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IIIB/IV NSCLC patients compared to standard treatment and supportive care.

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 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.

Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)Biological
Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.

Study groups in NCT01444118
Study group	Role	What they receive
EGF Vaccine	Experimental	Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care. Receives: Biological: Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)
Best Supportive Care	No intervention	Patients 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.

Overall Survival (OS)
Measured: Each patient will be followed till death occurs within the time frame of study of 3 years

Secondary outcomes (1)

To establish the safety of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients.
Measured: Each patients will be followed till death occurs within the time frame of study of 3 years

Timeline

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

Nov 2011Dec 2014

First posted30 Sep 2011 (estimated)
Study startNov 2011
Primary completionDec 2014
Study completionDec 2014

Why it stopped: The early termination is not related to safety/toxicity but to initiate new Phase III with biomarker to enrich population \& to further strengthen OS benefit

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: None (open label)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01444118
Sponsor's protocol ID: BV-NSCLC-001
Acronym: NSCLC
Status last verified: Jul 2015
First submitted: 29 Sep 2011
Last updated: 22 Jul 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoma, Non-Small-Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III, Open-label, Multicentre, Randomised Trial to Establish Safety and Efficacy of an EGF Cancer Vaccine in Inoperable, Late Stage (IIIb/IV) NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care.
ClinicalTrials.gov ID: NCT01444118
Acronym / sponsor ID: NSCLC / BV-NSCLC-001
Conditions: Carcinoma, Non-Small-Cell Lung
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The early termination is not related to safety/toxicity but to initiate new Phase III with biomarker to enrich population \& to further strengthen OS benefit
Lead sponsor: Bioven EuropeIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 30 Sep 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
EGF Vaccine	Experimental	Biological: Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.
Best Supportive Care	No intervention	–Patients in this arm will receive best supportive care

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Are aged 20-65 years (inclusive).
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:
Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced, inoperable disease (Stage IIIb or Stage IV [as defined by the American Joint Committee on Cancer staging system]), excluding brain metastases.
Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy or consolidation radiotherapy).

Key exclusion criteria (20 listed)

Patient has no measurable disease (as defined by RECIST criteria, version 1.1).
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.
Patient is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc. Use is not permitted within 1 month before Screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.	Biological	EGF Vaccine

Primary outcome

Overall Survival (OS)
Time frame: Each patient will be followed till death occurs within the time frame of study of 3 years

1 secondary outcome

To establish the safety of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients.
Time frame: Each patients will be followed till death occurs within the time frame of study of 3 years

Results and safety

The study was stopped early (reason given: The early termination is not related to safety/toxicity but to initiate new Phase III with biomarker to enrich population \& to further strengthen OS benefit). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.

Related trials for Carcinoma, Non-Small-Cell Lung

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marianne Nicolson, Dr. principal investigator

Aberdeen Royal Infirmary UK

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 20 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 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

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 the time frame of study 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 NCT01444118.

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 22 Jul 2015.