EUCTR2011-003719-42-ESActive, not recruitingNot Applicable
A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY ANDSAFETY OF MetMAb IN COMBINATION WITH EITHER BEVACIZUMAB+ PLATINUM + PACLITAXEL OR PEMETREXED + PLATINUM ASFIRST-LINE TREATMENT IN PATIENTS WITH STAGE IIIB or IVNON-SQUAMOUS NON?SMALL CELL LUNG CANCER (NSCLC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd.
- Enrollment
- 260
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •? Written informed consent
- •? Male or female, 18 years of age or older
- •? ECOG performance status of 0 or 1
- •? Stage IIIB or Stage IV NSCLC tumors of non-squamous histology (Stage IIIB eligible only if stage T4 disease not amenable to definitive surgery or radiation therapy)
- •? For patients who received prior adjuvant chemotherapy:
- •a treatment free interval of at least 12 months since the last chemotherapy cycle
- •? 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, if applicable.
- •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 169
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 91
Exclusion Criteria
- •? Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
- •? Mixed NSCLC histology with squamous cell predominance
- •? Prior exposure to experimental treatment targeting either the HGF or Met pathway
- •? Tumors confirmed to have EGFR activating mutations suitable for anti-EGFR therapy
- •? Known central nervous system (CNS) disease, other than stable, treated brain metastasis
- •? 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 or carboplatin
- •? (Patients with contraindications to bevacizumab or pemetrexed may not be included in those treatment cohorts)
Investigators
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