A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACYAND SAFETY OF MetMAb IN COMBINATION WITH PACLITAXEL + CISPLATIN OR CARBOPLATIN AS FIRST-LINE TREATMENT FOR PATIENTS WITH STAGE IIIB (T4 DISEASE) OR IV SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC)

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 110 人开始时间: 2012年3月6日最近更新: 2015年12月7日

适应症

试验速览

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•Written informed consent
•Male or female, 18 years of age or older
•ECOG performance status of 0 or 1
•Stage IIIB or IV NSCLC tumors of squamous histology (Stage IIIB NSCLC eligible only if not amenable to definitive surgery or radiation therapy) Patients with stable, treated brain metastases are eligible as long as there is no evidence of progression after treatment and no ongoing requirement for dexamethasone or other corticosteroid treatment.
•Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
•Adequate hematologic, hepatic, and renal function
•Adequate contraception, during the treatment period and for at least 90 days after the last dose of study drug/placebo or 6 months after the last dose of paclitaxel
•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 72
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 38

•Prior systemic treatment for Stage IIIB or IV squamous NSCLC
•NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
•Prior exposure to experimental treatment targeting either the HGF or Met pathway
•Tumors confirmed to have EGFR activating mutations who are suitable for anti-EGFR therapy
•Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1
•History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years (except for in situ cancer or basal or squamous cell skin cancer)
•Serum calcium > ULN corrected for low serum albumin concentrations
•Uncontrolled diabetes (fasting serum glucose level > 200 mg/dL)
•Pregnancy or lactation
•Significant history of cardiovascular disease
•Serious active infection or other serious underlying medical conditions
•Known HIV positivity
•Any major surgery, major surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1, or an anticipated need for major surgery during the study
•Known sensitivity to any component of cisplatin, carboplatin, or paclitaxel

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