EUCTR2005-004555-35-ES进行中（未招募）1 期
International, randomized, open-label, Phase 3 trial of paclitaxel/carboplatin plus PF-3512676 versus paclitaxel/carboplatin alone as first-line treatment of patients with advanced non-small cell lung cancerEnsayo internacional, aleatorizado, abierto, de fase 3 con paclitaxel/carboplatino más PF-3512676 frente a paclitaxel/carboplatino como tratamiento de primera línea en pacientes con cáncer de pulmón no microcítico avanzado
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer S.A
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- •Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
- •2. Advanced NSCLC with documented AJCC Stage IIIB (with pleural effusion) or Stage IV disease.
- •3. Measurable disease defined by at least one lesion that can be accurately measured in at least one dimension as >=20 mm with conventional techniques or >=10 mm with spiral CT scan within 28 days prior to the planned start of study treatment (RECIST criteria). Note: Prior radiation to the only site of measurable disease will deem the patient ineligible unless progression is documented at the site after completion of radiation.
- •4. No prior systemic treatment for NSCLC with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs.
- •5. Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to enrollment and all acute toxicities have resolved to baseline or to CTC Grade 1 (NCI CTCAE v3.0)
- •6. Males or females aged >=18 years
- •7. ECOG performance status (PS) 0 or 1
- •8. Adequate organ function as determine by the following criteria:
- •- Absolute neutrophil count (ANC) >=1.5 x 10 000 000 000/L.
- •- Platelet count >=100 x 10 000 000 000/L
- •- Serum creatinine =<1.5 x upper limit of normal (ULN)
- •- AST (SGOT) and ALT (SGPT) =<5 x ULN
- •- Total bilirubin =<1.25 x ULN
- •9. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within the 72 hours prior to starting treatment. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- •10. Written, voluntary informed consent provided
- •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
排除标准
- •1. Any histological/cytological evidence of small cell or carcinoid lung cancer.
- •2. Known central nervous system (CNS) metastasis.
- •CNS imaging is not required at baseline for patients who have no symptoms suggestive of CNS metastases
- •3. Any acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. This includes:
- •- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus, erythematosis, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, or glomerulonephritis.
- •- History of allogeneic transplant
- •- Untreated or uncontrolled superior vena cava syndrome
- •- Untreated or uncontrolled hypercalcemia
- •- Requirement for chronic treatment with therapeutic doses of systemic corticosteroids. Use of steroid inhalers, or oral physiologic replacement” doses of corticosteroids is permitted. Physiological replacement doses will be defined as =<37.5 mg/day of cortisone, =<7.5 mg/day of prednisolone or =<1.0 mg/day of dexamethasone. Patients on other replacement regimens must be discussed with the sponsor.
- •- Uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 12 months or serious uncontrolled cardiac arrhythmia.
- •- Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HBC) and human immunodeficiency virus (HIV). Serological testing will not be required at baseline for patients who have no symptoms suggestive of infection.
- •- Pre-existing peripheral neuropathy >= CTC Grade 2.
- •- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol.
- •4. History of any active malignancy (other than NSCLC) during the last 3 years except non melanoma skin cancer, in situ cervical cancer, or cured, early prostate cancer in a patient with PSA level < ULN.
- •5. Known or suspected hypersensitivity to any of the study drugs (paclitaxel, carboplatin or PF-3512676), study drug classes (taxane, platinum, oligodeoxynucleotide ODN) or excipients in the formulation of study drugs (including castor oil and derivatives such as Cremophor®)
- •6. Female patients who are pregnant or nursing.
- •7. Inability or lack of willingness to comply with scheduled visits, therapy plans or laboratory tests.
- •8. Current enrollment in another therapeutic clinical trial.
- •9. Use of any investigational agent in the past 4 weeks.
研究者
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