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

April 19, 2017 updated by: Peregrine Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

582

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Peregrine Pharmaceuticals Investigational Site
      • Camperdown, New South Wales, Australia, 2050
        • Peregrine Pharmaceuticals Investigational Site
      • Tweed Heads, New South Wales, Australia, 2485
        • Peregrine Pharmaceuticals Investigational Site
    • Queensland
      • Milton, Queensland, Australia, 4064
        • Peregrine Pharmaceuticals Investigational Site
      • Redcliffe, Queensland, Australia, 4020
        • Peregrine Pharmaceuticals Investigational Site
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Peregrine Pharmaceuticals Investigational Site
      • Toorak Gardens, South Australia, Australia, 5065
        • Peregrine Pharmaceuticals Investigational Site
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Peregrine Pharmaceuticals Investigational Site
      • Wodonga, Victoria, Australia, 3690
        • Peregrine Pharmaceuticals Investigational Site
  • Belgium
      • Antwerp, Belgium, 2020
        • Peregrine Pharmaceuticals Investigational Site
      • Bruxelles, Belgium, 1000
        • Peregrine Pharmaceuticals Investigational Site
      • Gent, Belgium, 9000
        • Peregrine Pharmaceuticals Investigational Site
      • Herstal, Belgium, 4040
        • Peregrine Pharmaceuticals Investigational Site
      • Liege, Belgium, 4000
        • Peregrine Pharmaceuticals Investigational Site
      • Mechelen, Belgium, 2800
        • Peregrine Pharmaceuticals Investigational Site
      • Namur, Belgium, 5000
        • Peregrine Pharmaceuticals Investigational Site
  • France
      • Rennes, France, 35033
        • Peregrine Pharmaceuticals Investigational Site
      • Saint Priest en Jarez, France, 42271
        • Peregrine Pharmaceuticals Investigational Site
      • Saint-Herblain, France, 44805
        • Peregrine Pharmaceuticals Investigational Site
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13273
        • Peregrine Pharmaceuticals Investigational Site
    • Calvados
      • Caen, Calvados, France, 14076
        • Peregrine Pharmaceuticals Investigational Site
    • Finistere
      • Brest, Finistere, France, 29609
        • Peregrine Pharmaceuticals Investigational Site
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44202
        • Peregrine Pharmaceuticals Investigational Site
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54100
        • Peregrine Pharmaceuticals Investigational Site
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64100
        • Peregrine Pharmaceuticals Investigational Site
  • Germany
      • Berlin, Germany, 12200
        • Peregrine Pharmaceuticals Investigational Site
      • Berlin, Germany, 13125
        • Peregrine Pharmaceuticals Investigational Site
      • Grosshansdorf, Germany, 22927
        • Peregrine Pharmaceuticals Investigational Site
      • Halle an der Saale, Germany, 06120
        • Peregrine Pharmaceuticals Investigational Site
      • Hamburg, Germany, 21075
        • Peregrine Pharmaceuticals Investigational Site
      • Kassel, Germany, 34125
        • Peregrine Pharmaceuticals Investigational Site
      • Mainz, Germany, 55131
        • Peregrine Pharmaceuticals Investigational Site
      • Munster, Germany, 48149
        • Peregrine Pharmaceuticals Investigational Site
      • Villingen-Schwenningen, Germany, 78052
        • Peregrine Pharmaceuticals Investigational Site
    • Baden-Wuerttemberg
      • Karlsruhe, Baden-Wuerttemberg, Germany, 76137
        • Peregrine Pharmaceuticals Investigational Site
    • Bayern
      • Munchen, Bayern, Germany, 81675
        • Peregrine Pharmaceuticals Investigational Site
    • Hessen
      • Immenhausen, Hessen, Germany, 34376
        • Peregrine Pharmaceuticals Investigational Site
      • Marburg, Hessen, Germany, 35043
        • Peregrine Pharmaceuticals Investigational Site
    • Nordrhein-Westfalen
      • Koln, Nordrhein-Westfalen, Germany, 51109
        • Peregrine Pharmaceuticals Investigational Site
    • Thuringia
      • Erfurt, Thuringia, Germany, 99089
        • Peregrine Pharmaceuticals Investigational Site
  • Greece
      • Athens, Greece, 11527
        • Peregrine Pharmaceuticals Investigational Site
      • Larissa, Greece, 41110
        • Peregrine Pharmaceuticals Investigational Site
      • Thessaloniki, Greece, 56429
        • Peregrine Pharmaceuticals Investigational Site
      • Thessaloniki, Greece, 57010
        • Peregrine Pharmaceuticals Investigational Site
    • Achaia
      • Patras, Achaia, Greece, 26500
        • Peregrine Pharmaceuticals Investigational Site
    • Athens
      • Neo Faliro, Athens, Greece, 18547
        • Peregrine Pharmaceuticals Investigational Site
    • Attiki
      • Athens, Attiki, Greece, 12464
        • Peregrine Pharmaceuticals Investigational Site
    • Crete
      • Chania, Crete, Greece, 73300
        • Peregrine Pharmaceuticals Investigational Site
    • Irakleio
      • Heraklion, Irakleio, Greece, 71110
        • Peregrine Pharmaceuticals Investigational Site
    • Thessaloniki
      • Thermi, Thessaloniki, Greece, 57001
        • Peregrine Pharmaceuticals Investigational Site
  • Hungary
      • Budapest, Hungary, 1121
        • Peregrine Pharmaceuticals Investigational Site
      • Budapest, Hungary, 1125
        • Peregrine Pharmaceuticals Investigational Site
      • Gyor, Hungary, 9023
        • Peregrine Pharmaceuticals Investigational Site
      • Gyula, Hungary, 5703
        • Peregrine Pharmaceuticals Investigational Site
      • Szolnok, Hungary, 5004
        • Peregrine Pharmaceuticals Investigational Site
      • Torokbalint, Hungary, 2045
        • Peregrine Pharmaceuticals Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • Peregrine Pharmaceuticals Investigational Site
  • Italy
      • Bergamo, Italy, 24127
        • Peregrine Pharmaceuticals Investigational Site
      • Cremona, Italy, 26100
        • Peregrine Pharmaceuticals Investigational Site
      • Genova, Italy, 16132
        • Peregrine Pharmaceuticals Investigational Site
      • Milan, Italy, 20162
        • Peregrine Pharmaceuticals Investigational Site
      • Turin, Italy, 10126
        • Peregrine Pharmaceuticals Investigational Site
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Peregrine Pharmaceuticals Investigational Site
    • Lucca
      • Lido di Camaiore, Lucca, Italy, 55041
        • Peregrine Pharmaceuticals Investigational Site
    • Messina
      • Taormina, Messina, Italy, 98039
        • Peregrine Pharmaceuticals Investigational Site
    • Monza Brianza
      • Monza, Monza Brianza, Italy, 20900
        • Peregrine Pharmaceuticals Investigational Site
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Peregrine Pharmaceuticals Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-702
        • Peregrine Pharmaceuticals Investigational Site
      • Cheongju-si, Korea, Republic of, 361711
        • Peregrine Pharmaceuticals Investigational Site
      • Incheon, Korea, Republic of, 400-711
        • Peregrine Pharmaceuticals Investigational Site
      • Seongnam, Korea, Republic of, 463-707
        • Peregrine Pharmaceuticals Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Peregrine Pharmaceuticals Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Peregrine Pharmaceuticals Investigational Site
      • Seoul, Korea, Republic of, 156707
        • Peregrine Pharmaceuticals Investigational Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 443-380
        • Peregrine Pharmaceuticals Investigational Site
    • Gyonggi-do
      • Suwon, Gyonggi-do, Korea, Republic of, 442-723
        • Peregrine Pharmaceuticals Investigational Site
  • Romania
      • Brasov, Romania, 500091
        • Peregrine Pharmaceuticals Investigational Site
      • Cluj-Napoca, Romania, 400058
        • Peregrine Pharmaceuticals Investigational Site
      • Cluj-Napoca, Romania, 400349
        • Peregrine Pharmaceuticals Investigational Site
      • Ploiesti, Romania, 100337
        • Peregrine Pharmaceuticals Investigational Site
      • Suceava, Romania, 720237
        • Peregrine Pharmaceuticals Investigational Site
      • Turda, Romania, 401103
        • Peregrine Pharmaceuticals Investigational Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620036
        • Peregrine Pharmaceuticals Investigational Site
      • Kursk, Russian Federation, 305035
        • Peregrine Pharmaceuticals Investigational Site
      • Nizhny Novgorod, Russian Federation, 603081
        • Peregrine Pharmaceuticals Investigational Site
      • Obninsk, Russian Federation, 249036
        • Peregrine Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 194291
        • Peregrine Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • Peregrine Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 197758
        • Peregrine Pharmaceuticals Investigational Site
      • Yaroslavl, Russian Federation, 150054
        • Peregrine Pharmaceuticals Investigational Site
  • Spain
      • A Coruna, Spain, 15006
        • Peregrine Pharmaceuticals Investigational Site
      • Barcelona, Spain, 08003
        • Peregrine Pharmaceuticals Investigational Site
      • Barcelona, Spain, 08035
        • Peregrine Pharmaceuticals Investigational Site
      • Barcelona, Spain, 08041
        • Peregrine Pharmaceuticals Investigational Site
      • Madrid, Spain, 28007
        • Peregrine Pharmaceuticals Investigational Site
      • Madrid, Spain, 28040
        • Peregrine Pharmaceuticals Investigational Site
      • Madrid, Spain, 28041
        • Peregrine Pharmaceuticals Investigational Site
      • Madrid, Spain, 28050
        • Peregrine Pharmaceuticals Investigational Site
      • Malaga, Spain, 29010
        • Peregrine Pharmaceuticals Investigational Site
      • Valencia, Spain, 46017
        • Peregrine Pharmaceuticals Investigational Site
      • Valencia, Spain, 46026
        • Peregrine Pharmaceuticals Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Peregrine Pharmaceuticals Investigational Site
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Peregrine Pharmaceuticals Investigational Site
      • Manresa, Barcelona, Spain, 08243
        • Peregrine Pharmaceuticals Investigational Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Peregrine Pharmaceuticals Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Peregrine Pharmaceuticals Investigational Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Peregrine Pharmaceuticals Investigational Site
      • Putzu, Taiwan, 613
        • Peregrine Pharmaceuticals Investigational Site
      • Taichung, Taiwan, 402
        • Peregrine Pharmaceuticals Investigational Site
      • Taichung, Taiwan, 40705
        • Peregrine Pharmaceuticals Investigational Site
      • Tainan, Taiwan, 704
        • Peregrine Pharmaceuticals Investigational Site
      • Tainan City, Taiwan, 736
        • Peregrine Pharmaceuticals Investigational Site
      • Taipei, Taiwan, 100
        • Peregrine Pharmaceuticals Investigational Site
      • Taipei, Taiwan, 10449
        • Peregrine Pharmaceuticals Investigational Site
      • Taipei, Taiwan, 112
        • Peregrine Pharmaceuticals Investigational Site
      • Taoyuan, Taiwan, 333
        • Peregrine Pharmaceuticals Investigational Site
  • Ukraine
      • Chernivtsi, Ukraine, 58013
        • Peregrine Pharmaceuticals Investigational Site
      • Dnipropetrovsk, Ukraine, 49102
        • Peregrine Pharmaceuticals Investigational Site
      • Khmelnytskyi, Ukraine, 29009
        • Peregrine Pharmaceuticals Investigational Site
      • Kyiv, Ukraine, 03115
        • Peregrine Pharmaceuticals Investigational Site
      • Lutsk, Ukraine, 43018
        • Peregrine Pharmaceuticals Investigational Site
      • Uzhgorod, Ukraine, 88000
        • Peregrine Pharmaceuticals Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Peregrine Pharmaceuticals Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Peregrine Pharmaceuticals Investigational Site
      • Glendale, Arizona, United States, 85306
        • Peregrine Pharmaceuticals Investigational Site
    • California
      • Greenbrae, California, United States, 94904
        • Peregrine Pharmaceuticals Investigational Site
      • Los Angeles, California, United States, 90048
        • Peregrine Pharmaceuticals Investigational Site
      • Oceanside, California, United States, 92056
        • Peregrine Pharmaceuticals Investigational Site
      • Orange, California, United States, 92868
        • Peregrine Pharmaceuticals Investigational Site
      • West Hills, California, United States, 91307
        • Peregrine Pharmaceuticals Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Peregrine Pharmaceuticals Investigational Site
      • Saint Petersburg, Florida, United States, 33705
        • Peregrine Pharmaceuticals Investigational Site
      • Tampa, Florida, United States, 33612
        • Peregrine Pharmaceuticals Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • Peregrine Pharmaceuticals Investigational Site
      • Savannah, Georgia, United States, 31404
        • Peregrine Pharmaceuticals Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Peregrine Pharmaceuticals Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Peregrine Pharmaceuticals Investigational Site
    • Louisiana
      • Marrero, Louisiana, United States, 70006
        • Peregrine Pharmaceuticals Investigational Site
      • Shreveport, Louisiana, United States, 71101
        • Peregrine Pharmaceuticals Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Peregrine Pharmaceuticals Investigational Site
      • Frederick, Maryland, United States, 21701
        • Peregrine Pharmaceuticals Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Peregrine Pharmaceuticals Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Peregrine Pharmaceuticals Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Peregrine Pharmaceuticals Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Peregrine Pharmaceuticals Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Peregrine Pharmaceuticals Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Peregrine Pharmaceuticals Investigational Site
      • Middletown, Ohio, United States, 45042
        • Peregrine Pharmaceuticals Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Peregrine Pharmaceuticals Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Peregrine Pharmaceuticals Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Peregrine Pharmaceuticals Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Peregrine Pharmaceuticals Investigational Site
      • Knoxville, Tennessee, United States, 37909
        • Peregrine Pharmaceuticals Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Peregrine Pharmaceuticals Investigational Site
      • Nashville, Tennessee, United States, 37323
        • Peregrine Pharmaceuticals Investigational Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Peregrine Pharmaceuticals Investigational Site
      • Dallas, Texas, United States, 75201
        • Peregrine Pharmaceuticals Investigational Site
      • Dallas, Texas, United States, 75390
        • Peregrine Pharmaceuticals Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Peregrine Pharmaceuticals Investigational Site
      • Temple, Texas, United States, 76508
        • Peregrine Pharmaceuticals Investigational Site
    • Washington
      • Seattle, Washington, United States, 98108
        • Peregrine Pharmaceuticals Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
Drug: Docetaxel
Other Names:
  • Taxotere
Biological: bavituximab
PLACEBO_COMPARATOR: placebo plus docetaxel
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
Drug: Docetaxel
Other Names:
  • Taxotere
Other: Placebo (for bavituximab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Approximately up to 36 months
Approximately up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Approximately up to 36 months
Approximately up to 36 months
Overall Response Rate
Time Frame: Approximately up to 36 months
Approximately up to 36 months
Safety
Time Frame: Approximately up to 36 months
As measured by adverse event rates and laboratory evaluations
Approximately up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peregrine Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

November 25, 2013

First Posted (ESTIMATE)

December 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPHM 1202
  • 2013-003953-13 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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