Non-Squamous Non-Small Cell Lung CancerPhase 3NCT01887886
A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation
A Phase 3 study testing erlotinib and onartuzumab in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 35 sites in 8 countries.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- erlotinib and onartuzumab
- 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
- 10 participants
- Where
- 35 sitesin 8 countries
- Study dates
- Dec 2013to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Adult patient, >/= 18 years of age
- Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- No prior treatment for unresectable Stage IIIB or IV NSCLC
- Measurable radiographic evidence of disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
- Exposure to an investigational or marketed agent that can act by EGFR inhibition
- Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
- Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.
- History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
- Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
Show all 10Show fewer
- Inadequate hematologic, biochemical, and organ function
- Pregnant or lactating women
- Life expectancy of < 12 weeks
- Receipt of an investigational drug within 28 days prior to initiation of study treatment
Trial locations and contacts
35 sites in 8 countries.
35 sites in 8 countries
United States15 sites
Study site
Bakersfield, California, 93309
Study site
Canton, Ohio, 44718
Study site
Chicago, Illinois, 60637
Study site
Fort Myers, Florida, 33905
Study site
Fullerton, California, 92835
Study site
Long Beach, California, 90813
Study site
Los Angeles, California, 90095-1772
Study site
Los Angeles, California, 90095
Study site
Marrero, Louisiana, 70072
Study site
Metairie, Louisiana, 70006
Study site
Nashville, Tennessee, 37203
Study site
Orlando, Florida, 32803
Study site
San Luis Obispo, California, 93454
Study site
St Louis, Missouri, 63110
Study site
St. Petersburg, Florida, 33705
Spain5 sites
Study site
Barcelona, Barcelona, 08025
Study site
Barcelona, Barcelona, 08035
Study site
Madrid, Madrid, 28007
Study site
Madrid, Madrid, 28050
Study site
Madrid, Madrid, 28222
France3 sites
Study site
Caen, 14076
Study site
Lyon, 69373
Study site
Nantes, 44805
Germany3 sites
Study site
Großhansdorf, 22927
Study site
Oldenburg, 26121
Study site
Villingen-Schwenningen, 78052
Japan3 sites
Study site
Ehime, 791-0280
Study site
Okayama, 700-8558
Study site
Yamaguchi, 755-0241
Taiwan3 sites
Study site
Taichung, 40447
Study site
Taipei, 00112
Study site
Taipei, 100
About this study
Official title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- erlotinib, onartuzumab, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinibDrug
150 mg orally daily
onartuzumabDrug
15 mg/kg IV every 3 weeks
placeboDrug
IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Onartuzumab + Erlotinib | Experimental | Not described Receives: Drug: erlotinib; Drug: onartuzumab |
| Placebo + Erlotinib | Active comparator | Not described Receives: Drug: erlotinib; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (investigator-assessed according to RECIST v1.1)
Measured: approximately 3 years
Secondary outcomes (6)
Overall survival
Measured: approximately 3 years
Overall response rate
Measured: approximately 3 years
Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms
Measured: approximately 3 years
Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires
Measured: approximately 3 years
Safety: Incidence of adverse events
Measured: approximately 3 years
Pharmacokinetics: Area under the concentration-time curve (AUC)
Measured: Day 1 Cycles 1, 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887886
- Sponsor's protocol ID
- GO28758
- Other IDs
- 2013-000868-29
- Status last verified
- Nov 2016
- First submitted
- 25 Jun 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation
- ClinicalTrials.gov ID
- NCT01887886
- Acronym / sponsor ID
- GO28758
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onartuzumab + Erlotinib | Experimental | Drug: erlotinib, Drug: onartuzumab |
| Placebo + Erlotinib | Active comparator | Drug: erlotinib, Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient, >/= 18 years of age
- Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- No prior treatment for unresectable Stage IIIB or IV NSCLC
- Measurable radiographic evidence of disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (10 listed)
- Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
- Exposure to an investigational or marketed agent that can act by EGFR inhibition
- Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
- Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.
- History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
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 |
|---|---|---|
| erlotinib150 mg orally daily | Drug | Onartuzumab + Erlotinib, Placebo + Erlotinib |
| onartuzumab15 mg/kg IV every 3 weeks | Drug | Onartuzumab + Erlotinib |
| placeboIV every 3 weeks | Drug | Placebo + Erlotinib |
Primary outcome
Progression-free survival (investigator-assessed according to RECIST v1.1)
Time frame: approximately 3 years
6 secondary outcomes
Overall survival
Time frame: approximately 3 years
Overall response rate
Time frame: approximately 3 years
Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms
Time frame: approximately 3 years
Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires
Time frame: approximately 3 years
Safety: Incidence of adverse events
Time frame: approximately 3 years
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Day 1 Cycles 1, 2 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
35 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing erlotinib and onartuzumab in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 35 sites in 8 countries.
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 5 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Spain, France, Germany, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (investigator-assessed according to RECIST v1.1) (time frame: approximately 3 years). 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 2 Nov 2016.