Non-Small Cell Lung CancerPhase 2NCT00854308
A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
A Phase 2 study testing Erlotinib HCl and MetMAb in people with Non-Small Cell Lung Cancer, run by Genentech, Inc..
Trial summary
This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Erlotinib HCl and MetMAb
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following criteria for study entry:
- Histologically confirmed NSCLC
- Availability of a tumor specimen
- Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease
- Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
- At least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose-positron emission tomography (FDG-PET) scan that is also a target lesion on computed tomography (CT) according to RECIST
Who cannot join
- More than two prior treatments for Stage IIIB/IV
- More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known epidermal growth factor receptor (EGFR)-related toxicity resulting in dose modifications
- Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
- Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis
- History of serious systemic disease within the past 6 months prior to randomization
- Uncontrolled diabetes
Show all 10Show fewer
- 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
- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
About this study
Official title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Erlotinib HCl, MetMAb, placebo (0.9 % saline)
- Keywords
- Tarceva, Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib HClDrug
Also called Tarceva
Erlotinib 150 mg oral dose once daily.
MetMAbDrug
MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.
placebo (0.9 % saline)Drug
Placebo Intravenous infusion every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MetMAb + Erlotinib | Experimental | MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. Receives: Drug: Erlotinib HCl; Drug: MetMAb |
| Placebo + Erlotinib | Placebo comparator | Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity. Receives: Drug: Erlotinib HCl; Drug: placebo (0.9 % saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
Measured: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
Progression-free Survival in Patients With Met Diagnostic-Positive Tumors
Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry.
PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
Measured: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
Secondary outcomes (3)
Percentage of Participants With Objective Response
Objective response (partial and complete response as determined using RECIST 1.0).
Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.
Complete response was defined as disappearance of all target lesions.
Measured: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors
Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry.
Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.
Complete response was defined as disappearance of all target lesions.
Measured: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
Duration of Overall Response
Measured: Date of initial response until date of progression or death on study. (Up to 20 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Premal Patel, M.D., Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854308
- Sponsor's protocol ID
- OAM4558g
- Status last verified
- Nov 2012
- First submitted
- 27 Feb 2009
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
- ClinicalTrials.gov ID
- NCT00854308
- Acronym / sponsor ID
- OAM4558g
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Tarceva, Lung Cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Posted 18 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MetMAb + Erlotinib | Experimental | Drug: Erlotinib HCl, Drug: MetMAbMetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. |
| Placebo + Erlotinib | Placebo comparator | Drug: Erlotinib HCl, Drug: placebo (0.9 % saline)Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed NSCLC
- Availability of a tumor specimen
- Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease
- Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
- At least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose-positron emission tomography (FDG-PET) scan that is also a target lesion on computed tomography (CT) according to RECIST
Key exclusion criteria (10 listed)
- More than two prior treatments for Stage IIIB/IV
- More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known epidermal growth factor receptor (EGFR)-related toxicity resulting in dose modifications
- Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
- Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis
- History of serious systemic disease within the past 6 months prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erlotinib HClAlso: TarcevaErlotinib 150 mg oral dose once daily. | Drug | MetMAb + Erlotinib, Placebo + Erlotinib |
| MetMAbMetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks. | Drug | MetMAb + Erlotinib |
| placebo (0.9 % saline)Placebo Intravenous infusion every 3 weeks. | Drug | Placebo + Erlotinib |
Primary outcome
Progression-free Survival
Time frame: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
Progression-free Survival in Patients With Met Diagnostic-Positive Tumors
Time frame: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry. PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
3 secondary outcomes
Percentage of Participants With Objective Response
Time frame: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors
Time frame: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
Duration of Overall Response
Time frame: Date of initial response until date of progression or death on study. (Up to 20 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Premal Patel, M.D., Ph.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib HCl and MetMAb in people with Non-Small Cell Lung Cancer, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.