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Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy
Bu çalışma, ileri evre küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) olan hastalarda birinci basamak kemoterapi sonrasında Lucanix™ aşı tedavisini plasebo ile karşılaştırarak değerlendirmektedir. Çalışmaya, histolojik olarak doğrulanmış evre IIIA, IIIB veya IV NSCLC bulunan, önceki platin bazlı kemoterapiye stabil kalmış ya da yanıt vermiş, 18-75 yaş arası hastalar katılabilmiştir. Çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * 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 an objective response (PR or CR) to 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 four weeks 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. 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.