ot applicable

Phase 1

• Conditions: late stage (IIIb/IV) Non-small cell lung carcinoma; MedDRA version: 15.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020023-43-GB
• Lead Sponsor: Bioven (Europe) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-22
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

1.Are aged 20-65 years (inclusive).
2.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3.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
4.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.
5.Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy or consolidation radiotherapy).
6.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.
7.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 range 438
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient has no measurable disease (as defined by RECIST criteria, version 1.1).
2.Patient is a candidate for concurrent chemo-radiotherapy or post chemo thoracic radiotherapy.
3.Patient has a history of known or suspected central nervous system (CNS) metastases.
4.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.
5.Patient is taking immunosuppressant drugs such as azathioprine, tacrolimus, ciclosporine, etc. Use is not permitted within 1 month before Screening.
6.Patient is taking any other immunotherapy.
7.Patient has primary or secondary immunodeficiencies (e.g. documented Human Immunodeficiency Virus [HIV]).
8.Patient has autoimmune disease.
9.Patient has undergone splenectomy.
10.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.
11.Patient has a neurotoxicity (Grade =2).
12.Patient has diarrhoea (Grade =2).
13.Patient has received other vaccines (with the exception of the influenza vaccine), within 1 month before Screening.
14.Patient has a history of any severe or life-threatening hypersensitivity reaction.
15.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).
16.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.
17.Patient has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions.
18.Patient is currently enrolled in an investigational device or drug trial, or <1 month since completing an investigational device or drug trial.
19.Female patients who are pregnant or lactating.
20.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
Main Objective: To assess overall survival (OS) of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients when compared to the control group receiving best treatment and supportive care.;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, late stage (IIIb/IV) NSCLC patients. <br>;Primary end point(s): Overall survival.;Timepoint(s) of evaluation of this end point: All study visits

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Progression-free survival.<br>•Survival rate.<br>•Time to progression.<br>•Response rate (RECIST criteria, version 1.1).<br>•Quality of Life – SF-36 v2 questionnaire.<br>•Safety (including AEs, laboratory evaluation, vital signs, physical examination).<br>;Timepoint(s) of evaluation of this end point: Visit 1: Response rate <br>Visit 2a: Response rate(if required), Quality of Life, Safety<br>Visit 2b, 2c: Response rate(if required), Progression-free survival, Survival rate, Time to progression, Quality of Life, Safety<br>Visits 3a, 3b, 3c, etc: Response rate (at the end of every two cycles of chemotherapy), Progression-free survival, Survival rate, Time to progression, Quality of Life, Safety<br>Visit 4a, 4b, 4c etc: Progression-free survival, Survival rate, Time to progression, Response rate (if required), Quality of Life, Safety <br>Visits 5a, 5b, 5c, etc: Survival rate, Safety<br>