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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01456325




Registration number
NCT01456325
Ethics application status
Date submitted
18/10/2011
Date registered
20/10/2011
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)
Scientific 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
Secondary ID [1] 0 0
GO27761
Secondary ID [2] 0 0
OAM4971g
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Erlotinib
Treatment: Drugs - Onartuzumab (MetMab)
Treatment: Drugs - Placebo

Experimental: Onartuzumab+Erlotinib - Participants will receive onartuzumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally once daily (QD) from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.

Placebo comparator: Placebo+Erlotinib - Participants will receive onartuzumab matching placebo on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally QD from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.


Treatment: Drugs: Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.

Treatment: Drugs: Onartuzumab (MetMab)
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.

Treatment: Drugs: Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Secondary outcome [1] 0 0
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores
Timepoint [1] 0 0
Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months)
Secondary outcome [2] 0 0
Onartuzumab Serum Concentrations
Timepoint [2] 0 0
1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months)
Secondary outcome [3] 0 0
Percentage of Participants With Disease Progression or Death
Timepoint [3] 0 0
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Secondary outcome [5] 0 0
Percentage of Participants with an Objective Response Assessed Using RECIST V 1.1
Timepoint [5] 0 0
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)

Eligibility
Key inclusion criteria
* Adult participants, greater than or equal to (>/=) 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 immunohistochemistry (IHC)
* Results of endothelial growth factor receptor (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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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; participants 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 participant 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 human immunodefinciency (HIV) infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
494
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Chermside
Recruitment hospital [4] 0 0
- Adelaide
Recruitment hospital [5] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
5041 - Adelaide
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
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Serbia
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Belgrade
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Serbia
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Sandton
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Barcelona
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Madrid
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Sevilla
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Valencia
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Changhua
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Cherkassy
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Sumy
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Ukraine
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Zaporizhzhya
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Belfast
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Grimsby
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Leicester
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London
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Trial website
https://clinicaltrials.gov/study/NCT01456325
Trial related presentations / publications
Koeppen H, Yu W, Zha J, Pandita A, Penuel E, Rangell L, Raja R, Mohan S, Patel R, Desai R, Fu L, Do A, Parab V, Xia X, Januario T, Louie SG, Filvaroff E, Shames DS, Wistuba I, Lipkind M, Huang J, Lazarov M, Ramakrishnan V, Amler L, Phan SC, Patel P, Peterson A, Yauch RL. Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib+/-onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit. Clin Cancer Res. 2014 Sep 1;20(17):4488-98. doi: 10.1158/1078-0432.CCR-13-1836. Epub 2014 Mar 31.
Public notes

Contacts
Principal investigator
Name 0 0
Ivor Caro, M.D.
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01456325