Registration Phase III Study of Lucanix™ (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix™ Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line Platinum-based Combination Chemotherapy

• Conditions: on Small Cell Lung Cancer; MedDRA version: 9.1Level: LLTClassification code 10066490Term: Progression of non small cell lung cancer

• Registration Number: EUCTR2007-005234-36-HU
• Lead Sponsor: ovaRx Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-23
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 506

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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified