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: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10025048 Term: Lung cancer non-small cell recurrent System Organ Class: 100000004864
Conditions
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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/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 72 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
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 disease-free interval of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the duration of progression-free survival of MetMAb + paclitaxel + platinum (cisplatin or carboplatin) relative to placebo + paclitaxel + platinum in all enrolled patients and in the subgroup of patients with Met diagnostic–positive tumors;Secondary Objective: • To evaluate the duration of survival in patients who receive paclitaxel + platinum (cisplatin or carboplatin) MetMAb relative to placebo+ platinum (cisplatin or carboplatin) in all patients and in those with Met diagnostic–positive squamous NSCLC • To evaluate the overall response rate in patients who receive paclitaxel + platinum (cisplatin or carboplatin) MetMAb relative to placebo+ platinum (cisplatin or carboplatin) in all patients and in those with Met diagnostic–positive squamous NSCLC • To evaluate the safety and tolerability of MetMAb in patients who receive paclitaxel + platinum (cisplatin or carboplatin) MetMAb relative to placebo+ platinum (cisplatin or carboplatin) in all patients and in those with Met diagnostic–positive squamous NSCLC • To describe the pharmacokinetics (PK) of MetMAb when given with paclitaxel and platinum • To evaluate the possible effect of MetMAb on the PK of paclitaxel and platinum • To evaluate potential immune responses to MetMAb ;Primary end point(s): • Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: PFS will be evaluated when 44 investigator-assessed PFS events in patients with Met diagnostic-positive tumors and 88 PFS events in the ITT population have occurred. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival (OS) • Overall response rate (ORR) • Duration of response (DOR) • Disease control rate (DCR) • Adverse events, including serious AEs and potential antibodies against MetMAb • Clinical laboratory results and vital signs • Pharmacokinetics for all components of study treatments ;Timepoint(s) of evaluation of this end point: Follow-up for survival will continue until all patients have either died, or are lost to follow-up, or the Sponsor decides to end the trial, whichever occurs first. | — |
Countries
Argentina, Brazil, France, Germany, Israel, Italy, Latvia, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed