A study to evaluate the efficacy and the safety of MetMAb in combination with either bevacizumab + platinum + paclitaxel or pemetrexed + platinum in lung cancer patients (non-squamous non-small cell lung cancer).
- Conditions
- MET DIAGNOSTIC-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)MedDRA version: 14.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 100000004864MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864MedDRA version: 14.1 Level: LLT Classification code 10025048 Term: Lung cancer non-small cell recurrent System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003719-42-GB
- Lead Sponsor
- Genentech, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 259
• 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/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 169
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 91
• 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method