A study to evaluate the efficacy and the safety of MetMAb in combination with paclitaxel+cisplatin or paclitaxel+carboplatin in patients with either locally advanced or metastatic squamous 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: EUCTR2011-003720-12-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-02
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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, 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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

• 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 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, carboplatin, or paclitaxel

Study & Design

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