E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non Small Cell Lung Cancer |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066490 |
E.1.2 | Term | Progression of non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 evaluate Lucanix treatment of subjects with stages IIIA (T3N2 disease only), IIIB, or IV non-small cell lung cancer (NSCLC) who have stable disease (SD), or better (based on a comparison between the post-initiation chemotherapy scan and the baseline scan) following a frontline platinum-based chomotherapy regimen. |
|
E.2.2 | Secondary objectives of the trial |
The Secondary objectives of the study are to
-Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the BSC control group. -Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the Placebo control group. -Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the Placebo control group. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The inclusion criteria for registration into the protocol are:
-Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
-Stage IIIA (T3N2 only) or -Stage IIIB or -Stage IV.
-Subjects must have stable disease (SD) or better following a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
-Not less than one month nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
-Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
-Signed informed consent.
-Not less than 18 years and not more than 75 years old.
-Estimated life expectancy of at least 12 weeks.
-Performance status (ECOG) ≤ 2.
-Absolute neutrophil count ≥ 1,500/mm3.
-Hemoglobin ≥ 9 g/dL.
-Platelet count ≥ 100,000/mm3.
-Albumin levels ≥ 2.5 g/dL.
-Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
-Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
-Creatinine ≤ 1.5 × ULN.
-Alkaline phosphatase ≤ 5 × ULN. |
|
E.4 | Principal exclusion criteria |
-Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
-Prior splenectomy.
-Any surgery involving general anesthesia < 4 weeks prior to study registration.
-Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
-Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
-Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
-Painful bone metastases, or bone metastases that require immediate therapy.
-Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
-Known allergies to eggs or soy.
-Significant weight loss (≥ 10% body weight in preceding 6 weeks).
-Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
-Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
-NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
-Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
-History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
-Pregnant or nursing women, or refusal to practice contraception if of reproductive potential.
-Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
-Known active Epstein-Barr infection within ≤ 60 days of study registration. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint of this international study is to evaluate the ability of Lucanix™ to significantly prolong the overall survival of subjects with stages IIIA (T3N2 disease only), IIIB, or IV non-small cell lung cancer (NSCLC) who have stable disease (SD) or better (based on a comparison between the post-initiation chemotherapy scan and the baseline scan) following a frontline platinum-based chemotherapy regimen by at least 3 months (92 days) when compared to subjects on the control arm |
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
|
8 years or the death of the last surviving subject, in order to capture full overall survival data |
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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 | 8 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 8 |