Patients with advanced non-small cell lung cancer MedDRA version: 9.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Product Name: MetMAb
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: OA5D5
rhuMabOA5D5
PRO143966
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60mg/ml-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration o
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: •Signed, written informed consent prior to any study-specific screening procedures •Age = 18 years of age •ECOG performance status of 0, 1, or 2 (see Appendix D of the protocol) •Histologically confirmed NSCLC Availability at the site of a representative formalin-fixed, paraffin-embedded tumor specimen that enabled the definitive diagnosis of NSCLC with adequate viable tumor cells in a tissue block (preferred) or 15 unstained, serial slides, accompanied by an associated pathology report is required prior to randomization. Cytological samples are not acceptable. If the archival tissue is neither sufficient nor available, the patient may still be eligible, upon discussion with the Medical Monitor, assuming the patient: Can provide at least = 5 unstained, serial slides or Is willing to consent to and undergo a pre-treatment biopsy of the tumor •Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease Patients who receive neo-adjuvant and/or adjuvant therapy for Stage I-IIIa disease prior to their first-line regimen (for Stage IIIb/IV) are eligible for study participation, provided they also receive first-line therapy for Stage IIIb/IV disease At least one of the chemotherapy containing regimens (for any stage) must have been platinum-based •Measurable disease in accordance with RECIST (see Appendix C of the protocol) •At least one measurable lesion on a pre-treatment FDG-PET scan that is also a target lesion on CT according to RECIST (as determined by the site) At the time of the interim analysis, the IRF will decide whether additional PET imaging should be obtained on remaining patients and at which sites, if not in all. Following input from the IRF, this criterion may only apply to sites that will continue to perform FDG-PET imaging (see protocol Section 4.5.6). •Use of an acceptable means of contraception for men and women of childbearing potential 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: •More than two prior treatments for Stage IIIB/IV A change of chemotherapy regimen for reasons of patient intolerance or excessive toxicity does not constitute an additional regimen, unless disease progression was documented at the time of treatment change. Combined treatment with chemotherapy and radiation constitutes a single prior regimen Surgery does not constitute a prior regimen •More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications EGFR inhibitors include (but are not limited to) gefitinib, erlotinib, and cetuximab •Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization Exceptions are kinase inhibitors, which may be used within 2 weeks prior to randomization, provided that any drug-related toxicity has adequately resolved and prior approval has been obtained from the Medical Monitor •Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) CNS metastasis Patients with history of brain metastasis may be eligible for study participation, as long as they meet the following criteria: Measurable disease outside the CNS, as defined by RECIST No radiographic evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study Adequate CNS-directed treatment, which may include neurosurgery or stereotactic radiosurgery. The screening of CNS radiographic study is = 4 weeks since completion of radiotherapy and = 2 weeks since the discontinuation of corticosteroids and anticonvulsants Radiotherapy and/or stereotactic radiosurgery must be completed =4 weeks prior to Day 1 Neurosurgery must be completed = 24 weeks prior to Day 1, and brain biopsy must be completed = 12 weeks prior to Day 1 •History of serious systemic disease within the past 6 months prior to randomization, including myocardial infarction, uncontrolled hypertension (blood pressure > 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or Grade II or greater peripheral vascular disease •Uncontrolled diabetes as evidenced by fasting serum glucose level > 200mg/dL •Major surgical procedure or significant traumatic injury within 28 days prior to randomization •Anticipation of need for a major surgical procedure during the course of the study •Local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to Grade II or less prior to randomization •Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting gastrointestinal absorption •Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinical significant hypercalcemia are eligible •Any of the following abnormal hematologic values (within 2 weeks prior to randomization) ANC < 1,500 cells/µL Platelet count < 100,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate progression-free survival (PFS) of MetMAb + erlotinib, relative to erlotinib + placebo, in patients with Met positive tumors (as determined by immunohistochemistry), as well as overall.;Secondary Objective: •To determine the overall RECIST response rate and duration of response in patients with Met positive tumors, as well as overall •To characterize the safety and tolerability of MetMAb + erlotinib in patients with non small cell lung cancer (NSCLC) •To evaluate minimum concentration (Cmin) and maximum concentration (Cmax) of both MetMAb and erlotinib in patients with NSCLC ;Primary end point(s): -Median Patient Free Survival (PSF) for each treatment arm | — |
Countries
France, Poland
Outcome results
None listed