A study to evaluate the efficacy and the safety of MetMAb in combinationwith either bevacizumab + platinum + paclitaxel or pemetrexed +platinum in lung cancer patients (non-squamous non-small cell lungcancer).
- Conditions
- MET DIAGNOSTIC-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)MedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003719-42-IT
- Lead Sponsor
- F. HOFFMANN - LA ROCHE LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
• 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: 0
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 diseasefree
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