Non-Small-Cell Lung Cancer Stage IIIBPhase 3SUNRISENCT01999673

Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

A Phase 3 study testing bavituximab and Docetaxel in people with Non-Small-Cell Lung Cancer Stage IIIB and Non-Small-Cell Lung Cancer Stage IV, run by Peregrine Pharmaceuticals at 161 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small-Cell Lung Cancer Stage IIIB, Non-Small-Cell Lung Cancer Stage IV, Non-Small-Cell Lung Cancer Metastatic
What is being tested?: bavituximab and Docetaxel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 582 participants
Where: 161 sitesin 14 countries
Study dates: Dec 2013to Mar 2017
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

Male or female at least 18 years of age
Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate hematologic, renal and hepatic function

Who cannot join

Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
Cavitary tumors or tumors invading or abutting large blood vessels
Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
Grade 2 or higher peripheral neuropathy

Trial locations and contacts

161 sites in 14 countries.

Country

City, postcode or hospital

161 sites in 14 countries

United States39 sites

Peregrine Pharmaceuticals Investigational Site
Abilene, Texas, 79606
Peregrine Pharmaceuticals Investigational Site
Albuquerque, New Mexico, 87131
Peregrine Pharmaceuticals Investigational Site
Athens, Georgia, 30607
Peregrine Pharmaceuticals Investigational Site
Baltimore, Maryland, 21201
Peregrine Pharmaceuticals Investigational Site
Boston, Massachusetts, 02114
Peregrine Pharmaceuticals Investigational Site
Chandler, Arizona, 85224
Peregrine Pharmaceuticals Investigational Site
Chattanooga, Tennessee, 37404
Peregrine Pharmaceuticals Investigational Site
Chicago, Illinois, 60637
Peregrine Pharmaceuticals Investigational Site
Cincinnati, Ohio, 45242
Peregrine Pharmaceuticals Investigational Site
Dallas, Texas, 75201
Peregrine Pharmaceuticals Investigational Site
Dallas, Texas, 75390
Peregrine Pharmaceuticals Investigational Site
Fort Myers, Florida, 33916
Peregrine Pharmaceuticals Investigational Site
Fort Worth, Texas, 76104
Peregrine Pharmaceuticals Investigational Site
Frederick, Maryland, 21701
Peregrine Pharmaceuticals Investigational Site
Glendale, Arizona, 85306
Peregrine Pharmaceuticals Investigational Site
Greenbrae, California, 94904
Peregrine Pharmaceuticals Investigational Site
Hershey, Pennsylvania, 17033
Peregrine Pharmaceuticals Investigational Site
Huntsville, Alabama, 35805
Peregrine Pharmaceuticals Investigational Site
Indianapolis, Indiana, 46254
Peregrine Pharmaceuticals Investigational Site
Knoxville, Tennessee, 37909
Peregrine Pharmaceuticals Investigational Site
Lebanon, New Hampshire, 03756
Peregrine Pharmaceuticals Investigational Site
Lincoln, Nebraska, 68506
Peregrine Pharmaceuticals Investigational Site
Los Angeles, California, 90048
Peregrine Pharmaceuticals Investigational Site
Marrero, Louisiana, 70006
Peregrine Pharmaceuticals Investigational Site
Middletown, Ohio, 45042
Peregrine Pharmaceuticals Investigational Site
Nashville, Tennessee, 37203
Peregrine Pharmaceuticals Investigational Site
Nashville, Tennessee, 37323
Peregrine Pharmaceuticals Investigational Site
Oceanside, California, 92056
Peregrine Pharmaceuticals Investigational Site
Orange, California, 92868
Peregrine Pharmaceuticals Investigational Site
Pittsburgh, Pennsylvania, 15232
Peregrine Pharmaceuticals Investigational Site
Portland, Oregon, 97213
Peregrine Pharmaceuticals Investigational Site
Savannah, Georgia, 31404
Peregrine Pharmaceuticals Investigational Site
Seattle, Washington, 98108
Peregrine Pharmaceuticals Investigational Site
Shreveport, Louisiana, 71101
Peregrine Pharmaceuticals Investigational Site
St. Petersburg, Florida, 33705
Peregrine Pharmaceuticals Investigational Site
Tampa, Florida, 33612
Peregrine Pharmaceuticals Investigational Site
Temple, Texas, 76508
Peregrine Pharmaceuticals Investigational Site
West Hills, California, 91307
Peregrine Pharmaceuticals Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Spain16 sites

Peregrine Pharmaceuticals Investigational Site
A Coruña, 15006
Peregrine Pharmaceuticals Investigational Site
Badalona, Barcelona, 08916
Peregrine Pharmaceuticals Investigational Site
Barcelona, 08003
Peregrine Pharmaceuticals Investigational Site
Barcelona, 08035
Peregrine Pharmaceuticals Investigational Site
Barcelona, 08041
Peregrine Pharmaceuticals Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08908
Peregrine Pharmaceuticals Investigational Site
Madrid, 28007
Peregrine Pharmaceuticals Investigational Site
Madrid, 28040
Peregrine Pharmaceuticals Investigational Site
Madrid, 28041
Peregrine Pharmaceuticals Investigational Site
Madrid, 28050
Peregrine Pharmaceuticals Investigational Site
Majadahonda, Madrid, 28222
Peregrine Pharmaceuticals Investigational Site
Málaga, 29010
Peregrine Pharmaceuticals Investigational Site
Manresa, Barcelona, 08243
Peregrine Pharmaceuticals Investigational Site
Pamplona, Navarre, 31008
Peregrine Pharmaceuticals Investigational Site
Valencia, 46017
Peregrine Pharmaceuticals Investigational Site
Valencia, 46026

Other trials in Spain

Germany15 sites

Peregrine Pharmaceuticals Investigational Site
Berlin, 12200
Peregrine Pharmaceuticals Investigational Site
Berlin, 13125
Peregrine Pharmaceuticals Investigational Site
Cologne, North Rhine-Westphalia, 51109
Peregrine Pharmaceuticals Investigational Site
Erfurt, Thuringia, 99089
Peregrine Pharmaceuticals Investigational Site
Großhansdorf, 22927
Peregrine Pharmaceuticals Investigational Site
Halle, 06120
Peregrine Pharmaceuticals Investigational Site
Hamburg, 21075
Peregrine Pharmaceuticals Investigational Site
Immenhausen, Hesse, 34376
Peregrine Pharmaceuticals Investigational Site
Karlsruhe, Baden-Wurttemberg, 76137
Peregrine Pharmaceuticals Investigational Site
Kassel, 34125
Peregrine Pharmaceuticals Investigational Site
Mainz, 55131
Peregrine Pharmaceuticals Investigational Site
Marburg, Hesse, 35043
Peregrine Pharmaceuticals Investigational Site
München, Bavaria, 81675
Peregrine Pharmaceuticals Investigational Site
Münster, 48149
Peregrine Pharmaceuticals Investigational Site
Villingen-Schwenningen, 78052

Other trials in Germany

Greece10 sites

Peregrine Pharmaceuticals Investigational Site
Athens, Attica, 12464
Peregrine Pharmaceuticals Investigational Site
Athens, 11527
Peregrine Pharmaceuticals Investigational Site
Chania, Crete, 73300
Peregrine Pharmaceuticals Investigational Site
Heraklion, Irakleio, 71110
Peregrine Pharmaceuticals Investigational Site
Larissa, 41110
Peregrine Pharmaceuticals Investigational Site
Neo Faliro, Athens, 18547
Peregrine Pharmaceuticals Investigational Site
Pátrai, Achaia, 26500
Peregrine Pharmaceuticals Investigational Site
Thermi, Thessaloniki, 57001
Peregrine Pharmaceuticals Investigational Site
Thessaloniki, 56429
Peregrine Pharmaceuticals Investigational Site
Thessaloniki, 57010

Other trials in Greece

Italy10 sites

Peregrine Pharmaceuticals Investigational Site
Aviano, Pordenone, 33081
Peregrine Pharmaceuticals Investigational Site
Bergamo, 24127
Peregrine Pharmaceuticals Investigational Site
Cremona, 26100
Peregrine Pharmaceuticals Investigational Site
Genova, 16132
Peregrine Pharmaceuticals Investigational Site
Lido di Camaiore, Lucca, 55041
Peregrine Pharmaceuticals Investigational Site
Meldola, Forli-Cesena, 47014
Peregrine Pharmaceuticals Investigational Site
Milan, 20162
Peregrine Pharmaceuticals Investigational Site
Monza, Monza Brianza, 20900
Peregrine Pharmaceuticals Investigational Site
Taormina, Messina, 98039
Peregrine Pharmaceuticals Investigational Site
Turin, 10126

Other trials in Italy

Taiwan10 sites

Peregrine Pharmaceuticals Investigational Site
Kaohsiung City, 833
Peregrine Pharmaceuticals Investigational Site
Putzu, 613
Peregrine Pharmaceuticals Investigational Site
Taichung, 402
Peregrine Pharmaceuticals Investigational Site
Taichung, 40705
Peregrine Pharmaceuticals Investigational Site
Tainan, 704
Peregrine Pharmaceuticals Investigational Site
Tainan, 736
Peregrine Pharmaceuticals Investigational Site
Taipei, 100
Peregrine Pharmaceuticals Investigational Site
Taipei, 10449
Peregrine Pharmaceuticals Investigational Site
Taipei, 112
Peregrine Pharmaceuticals Investigational Site
Taoyuan, 333

Other trials in Taiwan

Australia9 sites

Peregrine Pharmaceuticals Investigational Site
Campbelltown, New South Wales, 2560
Peregrine Pharmaceuticals Investigational Site
Camperdown, New South Wales, 2050
Peregrine Pharmaceuticals Investigational Site
Elizabeth Vale, South Australia, 5112
Peregrine Pharmaceuticals Investigational Site
Geelong, Victoria, 3220
Peregrine Pharmaceuticals Investigational Site
Milton, Queensland, 4064
Peregrine Pharmaceuticals Investigational Site
Redcliffe, Queensland, 4020
Peregrine Pharmaceuticals Investigational Site
Toorak Gardens, South Australia, 5065
Peregrine Pharmaceuticals Investigational Site
Tweed Heads, New South Wales, 2485
Peregrine Pharmaceuticals Investigational Site
Wodonga, Victoria, 3690

Other trials in Australia

France9 sites

Peregrine Pharmaceuticals Investigational Site
Bayonne, Pyrenees-Atlantiques, 64100
Peregrine Pharmaceuticals Investigational Site
Brest, Finistere, 29609
Peregrine Pharmaceuticals Investigational Site
Caen, Calvados, 14076
Peregrine Pharmaceuticals Investigational Site
Marseille, Bouches-du-Rhone, 13273
Peregrine Pharmaceuticals Investigational Site
Nancy, Meurthe-et-Moselle, 54100
Peregrine Pharmaceuticals Investigational Site
Nantes, Loire-Atlantique, 44202
Peregrine Pharmaceuticals Investigational Site
Rennes, 35033
Peregrine Pharmaceuticals Investigational Site
Saint-Herblain, 44805
Peregrine Pharmaceuticals Investigational Site
Saint-Priest-en-Jarez, 42271

Other trials in France

South Korea9 sites

Peregrine Pharmaceuticals Investigational Site
Busan, 602-702
Peregrine Pharmaceuticals Investigational Site
Cheongju-si, 361711
Peregrine Pharmaceuticals Investigational Site
Incheon, 400-711
Peregrine Pharmaceuticals Investigational Site
Seongnam, 463-707
Peregrine Pharmaceuticals Investigational Site
Seoul, 135-710
Peregrine Pharmaceuticals Investigational Site
Seoul, 137-701
Peregrine Pharmaceuticals Investigational Site
Seoul, 156707
Peregrine Pharmaceuticals Investigational Site
Suwon, Gyeonggi-do, 443-380
Peregrine Pharmaceuticals Investigational Site
Suwon, Gyonggi-do, 442-723

Other trials in South Korea

Russia8 sites

Peregrine Pharmaceuticals Investigational Site
Kursk, 305035
Peregrine Pharmaceuticals Investigational Site
Nizhny Novgorod, 603081
Peregrine Pharmaceuticals Investigational Site
Obninsk, 249036
Peregrine Pharmaceuticals Investigational Site
Saint Petersburg, 194291
Peregrine Pharmaceuticals Investigational Site
Saint Petersburg, 197022
Peregrine Pharmaceuticals Investigational Site
Saint Petersburg, 197758
Peregrine Pharmaceuticals Investigational Site
Yaroslavl, 150054
Peregrine Pharmaceuticals Investigational Site
Yekaterinburg, 620036

Other trials in Russia

Belgium7 sites

Peregrine Pharmaceuticals Investigational Site
Antwerp, 2020
Peregrine Pharmaceuticals Investigational Site
Brussels, 1000
Peregrine Pharmaceuticals Investigational Site
Ghent, 9000
Peregrine Pharmaceuticals Investigational Site
Herstal, 4040
Peregrine Pharmaceuticals Investigational Site
Liège, 4000
Peregrine Pharmaceuticals Investigational Site
Mechelen, 2800
Peregrine Pharmaceuticals Investigational Site
Namur, 5000

Other trials in Belgium

Hungary7 sites

Peregrine Pharmaceuticals Investigational Site
Budapest, 1121
Peregrine Pharmaceuticals Investigational Site
Budapest, 1125
Peregrine Pharmaceuticals Investigational Site
Győr, 9023
Peregrine Pharmaceuticals Investigational Site
Gyula, 5703
Peregrine Pharmaceuticals Investigational Site
Szolnok, 5004
Peregrine Pharmaceuticals Investigational Site
Törökbálint, 2045
Peregrine Pharmaceuticals Investigational Site
Zalaegerszeg, 8900

Other trials in Hungary

Romania6 sites

Peregrine Pharmaceuticals Investigational Site
Brasov, 500091
Peregrine Pharmaceuticals Investigational Site
Cluj-Napoca, 400058
Peregrine Pharmaceuticals Investigational Site
Cluj-Napoca, 400349
Peregrine Pharmaceuticals Investigational Site
Ploieşti, 100337
Peregrine Pharmaceuticals Investigational Site
Suceava, 720237
Peregrine Pharmaceuticals Investigational Site
Turda, 401103

Other trials in Romania

Ukraine6 sites

Peregrine Pharmaceuticals Investigational Site
Chernivtsi, 58013
Peregrine Pharmaceuticals Investigational Site
Dnipropetrovsk, 49102
Peregrine Pharmaceuticals Investigational Site
Khmelnytskyi, 29009
Peregrine Pharmaceuticals Investigational Site
Kyiv, 03115
Peregrine Pharmaceuticals Investigational Site
Lutsk, 43018
Peregrine Pharmaceuticals Investigational Site
Uzhhorod, 88000

Other trials in Ukraine

About this study

Official title: SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer

Conditions: Non-Small-Cell Lung Cancer Stage IIIB, Non-Small-Cell Lung Cancer Stage IV, Non-Small-Cell Lung Cancer Metastatic, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma
Being tested: bavituximab, Docetaxel, Placebo (for bavituximab)
Keywords: SUNRISE, PPHM 1202, Bavituximab, Peregrine
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bavituximabBiological
DocetaxelDrug
Also called Taxotere
Placebo (for bavituximab)Other

Study groups in NCT01999673
Study group	Role	What they receive
bavituximab plus docetaxel	Experimental	Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression. Receives: Biological: bavituximab; Drug: Docetaxel
placebo plus docetaxel	Placebo comparator	Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression. Receives: Drug: Docetaxel; Other: Placebo (for bavituximab)

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
Measured: Approximately up to 36 months

Secondary outcomes (3)

Progression-free survival
Measured: Approximately up to 36 months
Overall Response Rate
Measured: Approximately up to 36 months
Safety
As measured by adverse event rates and laboratory evaluations
Measured: Approximately up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Mar 2017

First posted3 Dec 2013 (estimated)
Study startDec 2013
Primary completionMar 2017
Study completionMar 2017

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-Small-Cell Lung Cancer Stage IIIBStudies of the same condition, open and under way.
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: 582 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01999673
Sponsor's protocol ID: PPHM 1202
Other IDs: 2013-003953-13
Acronym: SUNRISE
Status last verified: Apr 2017
First submitted: 25 Nov 2013
Last updated: 21 Apr 2017
Results posted: No
Data monitoring committee: Yes

Publications

Gerber DE, Horn L, Boyer M, Sanborn R, Natale R, Palmero R, Bidoli P, Bondarenko I, Germonpre P, Ghizdavescu D, Kotsakis A, Lena H, Losonczy G, Park K, Su WC, Tang M, Lai J, Kallinteris NL, Shan JS, Reck M, Spigel DR. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer. Ann Oncol. 2018 Jul 1;29(7):1548-1553. doi: 10.1093/annonc/mdy177.
PubMed 29767677

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer
ClinicalTrials.gov ID: NCT01999673
Acronym / sponsor ID: SUNRISE / PPHM 1202
Conditions: Non-Small-Cell Lung Cancer Stage IIIB, Non-Small-Cell Lung Cancer Stage IV, Non-Small-Cell Lung Cancer Metastatic, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma
Keywords: SUNRISE, PPHM 1202, Bavituximab, Peregrine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 582 participants (estimated)
Lead sponsor: Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 3 Dec 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
bavituximab plus docetaxel	Experimental	Biological: bavituximab, Drug: DocetaxelSix 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
placebo plus docetaxel	Placebo comparator	Drug: Docetaxel, Other: Placebo (for bavituximab)Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female at least 18 years of age
Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate hematologic, renal and hepatic function

Key exclusion criteria (6 listed)

Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
Cavitary tumors or tumors invading or abutting large blood vessels
Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening

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
bavituximab	Biological	bavituximab plus docetaxel
DocetaxelAlso: Taxotere	Drug	bavituximab plus docetaxel, placebo plus docetaxel
Placebo (for bavituximab)	Other	placebo plus docetaxel

Primary outcome

Overall Survival
Time frame: Approximately up to 36 months

3 secondary outcomes

Progression-free survival
Time frame: Approximately up to 36 months
Overall Response Rate
Time frame: Approximately up to 36 months
Safety
Time frame: Approximately up to 36 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 21 Apr 2017.
Derived from this study: PubMed 29767677Gerber DE, Horn L, Boyer M, Sanborn R, Natale R, Palmero R, Bidoli P, Bondarenko I, Germonpre P, Ghizdavescu D, Kotsakis A, Lena H, Losonczy G, Park K, Su WC, Tang M, Lai J, Kallinteris NL, Shan JS, Reck M, Spigel DR. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer. Ann Oncol. 2018 Jul 1;29(7):1548-1553. doi: 10.1093/annonc/mdy177.

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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.

The record lists no contact. Use the official record to reach the sponsor.

161 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, Spain, Germany, Greece, Italy and 9 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. 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 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?

Overall Survival (time frame: Approximately up to 36 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 NCT01999673, 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 21 Apr 2017.