E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Non Small Cell Lung Cancer (NSCLC) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the percentage of progression at six months of HLA-A*0201 positive vaccinated and HLA-A*0201 negative non vaccinated patients
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E.2.2 | Secondary objectives of the trial |
•To study HLA-A*0201 positive vaccinated and HLA-A*0201 negative non vaccinated patients for - Time to tumor progression (TTP) - Overall survival (OS) •Correlate percentage of progression at six months with level of TERT expression by tumors in vaccinated patients •Evaluate immune response •Evaluate safety profile
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patients have given written informed consent before any study related activities are carried out •Histologically documented unresectable stage III and IV NSCLC. All histological subtypes are acceptable. Cancer stage must be confirmed and documented by computer tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) scan or whole body radionuclear body scan. •Documented stable disease or objective response after primary chemotherapy or chemo-radiotherapy (minimum two cycles of platine-based or non-platine-based chemotherapy and a minimum radiation dose of ≥ 50Gy) for unresectable stage III/IV disease. •Patients must have completed the primary chemotherapy or chemo-radiotherapy at least four weeks and no later than eight weeks before entering study. •WHO performance status 0-1 •Neutrophils >1500/µl, lymphocytes >1000/µl, platelets >105/µl, Hgb >10g/dl •Male or female ≥ 18 years of age
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E.4 | Principal exclusion criteria |
•Receipt of immunotherapy (interferons, interleukins, TNF, GM-CSF, G-CSF, M-CSF) within one month before entering study •A documented autoimmune or immunodeficiency disease. •Known HBV, HCV or HIV infections •Past or current history of neoplasm other than lung cancer, except for curatively treated non-melanoma skin cancer and in situ carcinoma of the cervix. •Hepatic dysfunction (ALT>2.5 times normal upper limit, AST>2.5 times normal upper limits, bilirubin≥1.5 times normal upper limit. •Renal dysfunction (serum creatinine≥2mg/dl) •Congestive heart failure, uncontrolled angina, uncontrolled hypertension, uncontrolled arrhythmia, myocardial infraction in the previous 6 months •Acute or chronic infectious disease •Pregnant or breast-feeding women •Simultaneous participation in another clinical study •Known alcohol/drug abuse •Requires concurrent treatment with a non-permitted drug.
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E.5 End points |
E.5.1 | Primary end point(s) |
•To study the percentage of progression at six months of HLA-A*0201 positive vaccinated and HLA-A*0201 negative non vaccinated patients
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | |