Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01519804
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing cisplatin/carboplatin, onartuzumab and paclitaxel in people with Non-Squamous Non-Small Cell Lung Cancer, run by Genentech, Inc. at 69 sites in 9 countries.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous 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-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- cisplatin/carboplatin, onartuzumab and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 69 sitesin 9 countries
- Study dates
- Apr 2012to Sep 2015
- Phase
- Phase 2
- 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 patients, >/= 18 years of age
- Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No prior chemotherapy for squamous NSCLC
- Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
- Radiographic evidence of disease
Who cannot join
- Prior systemic treatment for Stage IIIB or IV squamous NSCLC
- NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
- Prior exposure to experimental treatment targeting either the HGF or Met pathway
- Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
- Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
- History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
Show all 11Show fewer
- Pregnant or lactating women
- Uncontrolled diabetes
- Impaired bone marrow, liver or renal function as defined by protocol
- Significant history of cardiovascular disease
- Positive for HIV infection
Trial locations and contacts
69 sites in 9 countries.
69 sites in 9 countries
United States34 sites
Study site
Bakersfield, California, 93309
Study site
Bend, Oregon, 97701
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02215
Study site
Boynton Beach, Florida, 33435
Study site
Chicago, Illinois, 60611
Study site
Cleveland, Ohio, 44195
Study site
Fort Wayne, Indiana, 46815
Study site
Fort Wayne, Indiana, 46845
Study site
Fullerton, California, 92835
Study site
Grand Junction, Colorado, 81502-1628
Study site
Harvey, Illinois, 60426
Study site
Hickory, North Carolina, 28602
Study site
Huntsville, Alabama, 35805
Study site
Indianapolis, Indiana, 46260
Study site
Las Vegas, Nevada, 89148
Study site
Los Angeles, California, 90024
Study site
Los Angeles, California, 90095-1772
Study site
Marietta, Georgia, 30060
Study site
Metairie, Louisiana, 70006
Study site
Middletown, Ohio, 45042
Study site
Minneapolis, Minnesota, 55454
Study site
Muncie, Indiana, 47303
Study site
Northridge, California, 91328
Study site
Orlando, Florida, 32804
Study site
Pittsburgh, Pennsylvania, 15232
Study site
Sacramento, California, 95817
Study site
San Luis Obispo, California, 93454
Study site
Santa Barbara, California, 93105
Study site
Scottsdale, Arizona, 85259
Study site
Seattle, Washington, 98195
Study site
St Louis, Missouri, 63110
Study site
Stanford, California, 94305
Study site
Weston, Florida, 33331
Germany6 sites
Study site
Berlin, 12203
Study site
Göttingen, 37075
Study site
Halle, 06120
Study site
Immenhausen, 34376
Study site
München, 81925
Study site
Münster, 48149
Italy5 sites
Study site
Avellino, Campania, 83100
Study site
Cremona, Lombardy, 26100
Study site
Milan, Lombardy, 20133
Study site
Naples, Campania, 80131
Study site
Udine, Friuli Venezia Giulia, 33100
Spain5 sites
Study site
Barcelona, Barcelona, 08036
Study site
Madrid, Madrid, 28007
Study site
Madrid, Madrid, 28050
Study site
Pamplona, Navarre, 31008
Study site
Zaragoza, Zaragoza, 50009
France4 sites
Study site
Grenoble, 38043
Study site
Lyon, 69373
Study site
Paris, 75674
Study site
Rennes, 35033
Israel4 sites
Study site
Afula, 18101
Study site
Ashkelon, 78278
Study site
Tel Aviv, 6423906
Study site
Tsrifin, 6093000
Latvia4 sites
Study site
Daugavpils, 5417
Study site
Liepāja, LV 3401
Study site
Riga, LV 1079
Study site
Riga, LV-1002
United Kingdom4 sites
Study site
Aberdeen, AB25 2ZN
Study site
Birmingham, B9 5SS
Study site
Bournemouth, BH7 7DW
Study site
Leeds, LS9 7TF
Argentina3 sites
Study site
Buenos Aires, C1426ANZ
Study site
La Rioja, F5300COE
Study site
Santa Rosa, L6304BOC
About this study
Official title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- Placebo, cisplatin/carboplatin, onartuzumab, paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle
cisplatin/carboplatinDrug
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
onartuzumabDrug
Also called MetMAb
15 mg/kg iv, Day 1 of each 21-day cycle
paclitaxelDrug
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| MetMAb+paclitaxel+platinum | Experimental | Not described Receives: Drug: cisplatin/carboplatin; Drug: onartuzumab; Drug: paclitaxel |
| Placebo+paclitaxel+platinum | Active comparator | Not described Receives: Drug: Placebo; Drug: cisplatin/carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (tumor assessments according to RECIST criteria)
Measured: up to approximately 32 months
Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC
Measured: up to approximately 32 months
Secondary outcomes (8)
Overall survival
Measured: up to approximately 32 months
Overall response rate (tumor assessments according to RECIST criteria)
Measured: up to approximately 32 months
Duration of response (time from first documented objective response to disease progression)
Measured: up to approximately 32 months
Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)
Measured: up to approximately 32 months
Safety: Incidence of adverse events
Measured: up to approximately 32 months
Pharmacokinetics: serum concentration (Cmin/Cmax)
Measured: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years
Plasma concentrations of paclitaxel/platinum
Measured: Pre- and post-dose on Day 1 of Cycles 1 and 4
Serum levels of anti-therapeutic antibodies (MetMAb ATAs)
Measured: Pre-dose Day 1 of 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 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2014
- Study completionSep 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 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519804
- Sponsor's protocol ID
- GO27820
- Status last verified
- Sep 2016
- First submitted
- 19 Dec 2011
- Last updated
- 2 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. 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 Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01519804
- Acronym / sponsor ID
- GO27820
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Jan 2012 (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 efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy 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 |
|---|---|---|
| MetMAb+paclitaxel+platinum | Experimental | Drug: cisplatin/carboplatin, Drug: onartuzumab, Drug: paclitaxel |
| Placebo+paclitaxel+platinum | Active comparator | Drug: Placebo, Drug: cisplatin/carboplatin, Drug: paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No prior chemotherapy for squamous NSCLC
- Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
Key exclusion criteria (11 listed)
- Prior systemic treatment for Stage IIIB or IV squamous NSCLC
- NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
- Prior exposure to experimental treatment targeting either the HGF or Met pathway
- Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
- Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
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 |
|---|---|---|
| PlaceboMatching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle | Drug | Placebo+paclitaxel+platinum |
| cisplatin/carboplatinstandard dose iv, Day 1 of each 21-day cycle, 4 cycles | Drug | MetMAb+paclitaxel+platinum, Placebo+paclitaxel+platinum |
| onartuzumabAlso: MetMAb15 mg/kg iv, Day 1 of each 21-day cycle | Drug | MetMAb+paclitaxel+platinum |
| paclitaxel200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles | Drug | MetMAb+paclitaxel+platinum, Placebo+paclitaxel+platinum |
Primary outcome
Progression-free survival (tumor assessments according to RECIST criteria)
Time frame: up to approximately 32 months
Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC
Time frame: up to approximately 32 months
8 secondary outcomes
Overall survival
Time frame: up to approximately 32 months
Overall response rate (tumor assessments according to RECIST criteria)
Time frame: up to approximately 32 months
Duration of response (time from first documented objective response to disease progression)
Time frame: up to approximately 32 months
Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)
Time frame: up to approximately 32 months
Safety: Incidence of adverse events
Time frame: up to approximately 32 months
Pharmacokinetics: serum concentration (Cmin/Cmax)
Time frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years
Plasma concentrations of paclitaxel/platinum
Time frame: Pre- and post-dose on Day 1 of Cycles 1 and 4
Serum levels of anti-therapeutic antibodies (MetMAb ATAs)
Time frame: Pre-dose Day 1 of 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 Sep 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
Genentech, Inc.
69 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin/carboplatin, onartuzumab and paclitaxel in people with Non-Squamous Non-Small Cell Lung Cancer, run by Genentech, Inc. at 69 sites in 9 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 6 inclusion and 11 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 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Germany, Italy, Spain, France and 4 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 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?
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 (tumor assessments according to RECIST criteria) (time frame: up to approximately 32 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 2 Sep 2016.