ot Applicable
- Conditions
- late stage (IIIb/IV) Non-small cell lung carcinomaMedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005335-25-PL
- Lead Sponsor
- Bioven (Europe) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 418
1.Are aged 18 or older.
2.Have serum EGF concentration >250 pg/ml determined from sample taken at screening.
3.Have wild type EGF-R sequence.
4.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5.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)
•Total bilirubin = 1.5 x ULN
•Serum creatinine = 1.5 x ULN
6.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.
7.Are eligible to receive first-line platinum-containing chemotherapy (carboplatin or cisplatin with docetaxel, gemcitabine, paclitaxel, pemetrexed or vinorelbine, without concurrent radiotherapy to thorax measurable lesions or consolidation radiotherapy).
8.A female subject is eligible to participate if she is of:
Non-childbearing potential women refers to those women who are postmenopausal (with at least 2 years from last menstruation) or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the appropriate contraception methods in Section 8.1. This criterion must be followed during their participation in the study, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal
status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval
depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
A negative pregnancy test (based on the ß-subunit of HCG) must be documented at Screening for females of childbearing potential and use one of appropriate contraception methods in Section 8.1. This criterion must be followed during their participation in the study.
Note: Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile.
9.Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed during their participation in the study.
10.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age
1.Patient has no measurable disease (as defined by RECIST criteria, version 1.1).
2.Patient has EGF-R mutation.
3.Patient has EGF serum concentration below required threshold.
4.Patient is a candidate for concurrent chemo-radiotherapy or post chemo thoracic radiotherapy.
5.Patient has a history of known or suspected central nervous system (CNS) metastases.
6.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.
7.Patient is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc. Use is not permitted within 1 month before Screening.
8.Patient is taking any other immunotherapy.
9.Patient has primary or secondary immunodeficiencies (e.g. for Human Immunodeficiency Virus [HIV] confirmed positive test at screening).
10.Acute or chronic hepatitis B or hepatitis C infection. (confirmed positive test at screening for HBV and/or HCV)
11.Patient has autoimmune disease.
12.Patient has undergone splenectomy.
13.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.
14.Patient has neurotoxicity (Grade =2).
15.Patient has diarrhoea (Grade =2).
16.Patient has received other vaccines (with the exception of the influenza vaccine), within 1 month before Screening.
17.Patient has a history of any severe or life-threatening hypersensitivity reaction to the investigational drugs/components being administered in the study.
18.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).
19.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.
20.Patient has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions.
21.Patient is currently enrolled in an investigational device or drug trial, or <1 month since completing an investigational device or drug trial.
22.Female patients who are pregnant or lactating.
23.Patient has any other factor that in the opinion of the Investigator (or designee) would make the patient unsafe or unsuitable for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Overall survival.;Timepoint(s) of evaluation of this end point: All study visits;Main Objective: To assess overall survival (OS) of an EGF cancer vaccine in inoperable, stage IV biomarker positive, wild type EGF-R, NSCLC patients when compared to the control group receiving best treatment and supportive care.;<br> Secondary Objective: To assess progression-free survival (PFS), survival rate, time to progression (TTP), response rate (RECIST criteria) and quality of life (QoL).<br> To establish the safety of an EGF cancer vaccine in inoperable, stage IV NSCLC patients.<br>
- Secondary Outcome Measures
Name Time Method