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: 14.1Level: 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-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified