Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01366131
Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin, Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease (NILE)
A Phase 2 study testing MEGF0444A, bevacizumab and carboplatin in people with Non-Squamous Non-Small Cell Lung Cancer, run by Genentech, Inc. at 42 sites in 7 countries.
Trial summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or… 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?
- MEGF0444A, bevacizumab and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 42 sitesin 7 countries
- Study dates
- Jun 2011to Feb 2013
- 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
- Histologically or cytologically documented inoperable (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC). Diagnoses of non-squamous NSCLC that are based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predominant cell type.
- ECOG performance status of 0 or 1
- Life expectancy >12 weeks
- Measurable disease, as defined by RECIST 1.1
- Adequate hematologic and end organ function
Who cannot join
- Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors,radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before Day 1 of Cycle 1 for the treatment of Stage IV or recurrent NSCLC. Patients who received prior adjuvant chemotherapy or radiotherapy for NSCLC are not excluded if the time interval from completion of adjuvant therapy until disease progression is > 12 months.
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
- Pregnant and lactating women
- Active infection requiring IV antibiotics
- Bevacizumab-Specific Exclusions:
Show all 12Show fewer
- Histologically or cytologically documented inoperable, locally advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- Evidence of tumor invading major blood vessels on imaging
- Evidence of central nervous system (CNS) metastases
- History of stroke or transient ischemic attacks (TIAs) within 6 months prior to Day 1
- Significant vascular disease within 6 months prior to Day 1
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1
Trial locations and contacts
42 sites in 7 countries.
42 sites in 7 countries
United States20 sites
Study site
Albany, New York, 12208
Study site
Austin, Texas, 78731
Study site
Birmingham, Alabama, 35205
Study site
Burnsville, Minnesota, 55337
Study site
Columbus, Ohio, 43219
Study site
Fort Worth, Texas, 76104
Study site
Hershey, Pennsylvania, 17033
Study site
Hot Springs, Arkansas, 71913
Study site
Indianapolis, Indiana, 46260
Study site
Las Vegas, Nevada, 89148
Study site
Marietta, Georgia, 30060
Study site
Nashville, Tennessee, 37203
Study site
Orlando, Florida, 32904
Study site
Port Saint Lucie, Florida, 34952
Study site
Portland, Oregon, 97239
Study site
Santa Monica, California, 90404
Study site
St. Petersburg, Florida, 33719
Study site
Tampa, Florida, 33603
Study site
Vancouver, Washington, 98684
Study site
Wichita, Kansas, 67214-3728
France7 sites
Study site
Le Mans, 72037
Study site
Lyon, 69373
Study site
Marseille, 13273
Study site
Marseille, 13915
Study site
Paris, 75571
Study site
Saint-Herblain, 44805
Study site
Toulouse, 31059
Germany4 sites
Study site
Essen, 45122
Study site
Gauting, 82131
Study site
Großhansdorf, 22927
Study site
Halle, 06120
Hungary4 sites
Study site
Budapest, 1121
Study site
Budapest, 1125
Study site
Székesfehérvár, 8000
Study site
Tatabánya, 2800
Australia3 sites
Study site
Herston, Queensland, 4029
Study site
St Leonards, New South Wales, 2065
Study site
Woodville South, South Australia, 5011
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- MEGF0444A, bevacizumab, carboplatin, paclitaxel, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEGF0444ADrug
Intravenous repeating dose
bevacizumabDrug
Intravenous repeating dose
carboplatinDrug
Intravenous repeating dose
paclitaxelDrug
Intravenous repeating dose
placeboDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: MEGF0444A; Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel |
| B | Experimental | Not described Receives: Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)
Measured: Up to 24 months
Secondary outcomes (3)
Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1
Measured: Up to 24 months
Duration of objective response (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study)
Measured: Up to 24 months
Overall survival (defined as the time from randomization until death from any cause)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ina Rhee, M.D., Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366131
- Sponsor's protocol ID
- MEF4984g
- Other IDs
- GO27811
- Status last verified
- Nov 2016
- First submitted
- 2 Jun 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
von Pawel J, Spigel DR, Ervin T, Losonczy G, Barlesi F, Juhasz E, Anderson M, McCall B, Wakshull E, Hegde P, Ye W, Chen D, Chang I, Rhee I, Reck M. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jun;23(6):654-e58. doi: 10.1634/theoncologist.2017-0690. Epub 2018 Feb 7.
PubMed 29438092
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 Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease
- ClinicalTrials.gov ID
- NCT01366131
- Acronym / sponsor ID
- MEF4984g
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- First posted
- 3 Jun 2011 (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 is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MEGF0444A, Drug: bevacizumab, Drug: carboplatin, Drug: paclitaxel |
| B | Experimental | Drug: bevacizumab, Drug: carboplatin, Drug: paclitaxel, 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)
- Histologically or cytologically documented inoperable (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC). Diagnoses of non-squamous NSCLC that are based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predominant cell type.
- ECOG performance status of 0 or 1
- Life expectancy >12 weeks
- Measurable disease, as defined by RECIST 1.1
- Adequate hematologic and end organ function
Key exclusion criteria (12 listed)
- Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors,radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before Day 1 of Cycle 1 for the treatment of Stage IV or recurrent NSCLC. Patients who received prior adjuvant chemotherapy or radiotherapy for NSCLC are not excluded if the time interval from completion of adjuvant therapy until disease progression is > 12 months.
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
- Pregnant and lactating women
- Active infection requiring IV antibiotics
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 |
|---|---|---|
| MEGF0444AIntravenous repeating dose | Drug | A |
| bevacizumabIntravenous repeating dose | Drug | A, B |
| carboplatinIntravenous repeating dose | Drug | A, B |
| paclitaxelIntravenous repeating dose | Drug | A, B |
| placeboIntravenous repeating dose | Drug | B |
Primary outcome
Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)
Time frame: Up to 24 months
3 secondary outcomes
Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1
Time frame: Up to 24 months
Duration of objective response (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study)
Time frame: Up to 24 months
Overall survival (defined as the time from randomization until death from any cause)
Time frame: Up to 24 months
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.
- Derived from this study: PubMed 29438092von Pawel J, Spigel DR, Ervin T, Losonczy G, Barlesi F, Juhasz E, Anderson M, McCall B, Wakshull E, Hegde P, Ye W, Chen D, Chang I, Rhee I, Reck M. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jun;23(6):654-e58. doi: 10.1634/theoncologist.2017-0690. Epub 2018 Feb 7.
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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.
Ina Rhee, M.D., Ph.D. study director
Genentech, Inc.
42 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEGF0444A, bevacizumab and carboplatin in people with Non-Squamous Non-Small Cell Lung Cancer, run by Genentech, Inc. at 42 sites in 7 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 12 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 42 sites in United States, France, Germany, Hungary, Australia and 2 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 (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01366131, which also lists 1 linked publication.
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.