A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)
This study is currently recruiting participants.
Verified February 2013 by Genentech
Sponsor:
Genentech
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01456325
First received: October 18, 2011
Last updated: February 26, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in patients with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Patients will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with Tarceva. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: onartuzumab [MetMAb] Drug: erlotinib [Tarceva] Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Overall survival [ Time Frame: time from randomization to death due to any cause, up to approximately 40 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival, tumor assessments according to RECIST criteria [ Time Frame: time between date of randomization and the date of first documented disease progression or death, whichever occurs first, up to approximately 40 months ] [ Designated as safety issue: No ]
- Overall response rate (complete response + partial response) [ Time Frame: up to approximately 40 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: up to approximately 40 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 490 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: onartuzumab [MetMAb]
Repeating intravenous dose
Other Name: PRO143966
Drug: erlotinib [Tarceva]
Repeating oral dose
|
| Active Comparator: B |
Drug: erlotinib [Tarceva]
Repeating oral dose
Drug: Placebo
Repeating intravenous dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
- Met diagnostic-positive status tested by IHC
- Results of EGFR-activating mutation testing
- Radiographic evidence of disease
- Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1
- availability of tissue sample for diagnostic testing is required
Exclusion Criteria:
- 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 including but not limited to gefitinib, erlotinib and cetuximab)
- Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days
- History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; patients with prior history of non-invasive cancers are eligible
- Inadequate hematological, biochemical or organ function
- Significant history of cardiac disease
- Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment
- Any inflammatory changes of the surface of the eye
- Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
- Pregnant or lactating women
- Positive for HIV infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456325
Show 221 Study Locations
Contacts
| Contact: Please reference Study ID Number: GO27761 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 221 Study LocationsSponsors and Collaborators
Genentech
Hoffmann-La Roche
Investigators
| Study Director: | Holger Thurm, M.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01456325 History of Changes |
| Other Study ID Numbers: | OAM4971g, GO27761, 2011-002224-40 |
| Study First Received: | October 18, 2011 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013