Clinical trial NCT01999673: Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Nonsmall Cell Lung Cancer
Keywords: SUNRISE
PPHM 1202
Bavituximab
Peregrine
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-12-03
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: Approximately up to 36 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: Approximately up to 36 months
measure: Overall Response Rate
timeFrame: Approximately up to 36 months
measure: Safety
timeFrame: Approximately up to 36 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Arizona
city: Greenbrae
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: California
city: Los Angeles
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: California
city: Oceanside
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: California
city: Orange
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: California
city: West Hills
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: California
city: Fort Myers
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Florida
city: Tampa
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Florida
city: Athens
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Indiana
city: Marrero
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Maryland
city: Frederick
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Maryland
city: Boston
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Massachusetts
city: Lincoln
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Nebraska
city: Lebanon
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: New Hampshire
city: Albuquerque
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: New Mexico
city: Winston-Salem
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Ohio
city: Middletown
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Ohio
city: Portland
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Oregon
city: Hershey
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Tennessee
city: Abilene
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Texas
city: Dallas
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Texas
city: Dallas
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Texas
city: Temple
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Texas
city: Seattle
country: United States
facility: Peregrine Pharmaceuticals Investigational Site
state: Washington
city: Campbelltown
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: New South Wales
city: Camperdown
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: New South Wales
city: Tweed Heads
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: New South Wales
city: Milton
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: Queensland
city: Redcliffe
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: South Australia
city: Geelong
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: Victoria
city: Wodonga
country: Australia
facility: Peregrine Pharmaceuticals Investigational Site
state: Victoria
city: Antwerp
country: Belgium
facility: Peregrine Pharmaceuticals Investigational Site
city: Bruxelles
country: Belgium
facility: Peregrine Pharmaceuticals Investigational Site
city: Gent
country: Belgium
facility: Peregrine Pharmaceuticals Investigational Site
city: Herstal
country: Belgium
facility: Peregrine Pharmaceuticals Investigational Site
city: Liege
country: Belgium
facility: Peregrine Pharmaceuticals Investigational Site
city: Mechelen
country: Belgium
facility: Peregrine Pharmaceuticals Investigational Site
city: Namur
country: Belgium
facility: Peregrine Pharmaceuticals Investigational Site
city: Marseille
country: France
facility: Peregrine Pharmaceuticals Investigational Site
state: Bouches-du-Rhone
city: Caen
country: France
facility: Peregrine Pharmaceuticals Investigational Site
state: Calvados
city: Brest
country: France
facility: Peregrine Pharmaceuticals Investigational Site
state: Finistere
city: Nantes
country: France
facility: Peregrine Pharmaceuticals Investigational Site
state: Loire-Atlantique
city: Nancy
country: France
facility: Peregrine Pharmaceuticals Investigational Site
state: Meurthe-et-Moselle
city: Bayonne
country: France
facility: Peregrine Pharmaceuticals Investigational Site
state: Pyrenees-Atlantiques
city: Rennes
country: France
facility: Peregrine Pharmaceuticals Investigational Site
city: Saint Priest en Jarez
country: France
facility: Peregrine Pharmaceuticals Investigational Site
city: Saint-Herblain
country: France
facility: Peregrine Pharmaceuticals Investigational Site
city: Karlsruhe
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
state: Baden-Wuerttemberg
city: Munchen
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
state: Bayern
city: Immenhausen
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
state: Hessen
city: Marburg
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
state: Hessen
city: Koln
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
state: Nordrhein-Westfalen
city: Erfurt
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
state: Thuringia
city: Berlin
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Berlin
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Grosshansdorf
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Halle an der Saale
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Hamburg
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Kassel
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Mainz
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Munster
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: Peregrine Pharmaceuticals Investigational Site
city: Patras
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
state: Achaia
city: Neo Faliro
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
state: Athens
city: Athens
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
state: Attiki
city: Chania
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
state: Crete
city: Heraklion
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
state: Irakleio
city: Thermi
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
state: Thessaloniki
city: Athens
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
city: Larissa
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
city: Thessaloniki
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
city: Thessaloniki
country: Greece
facility: Peregrine Pharmaceuticals Investigational Site
city: Budapest
country: Hungary
facility: Peregrine Pharmaceuticals Investigational Site
city: Budapest
country: Hungary
facility: Peregrine Pharmaceuticals Investigational Site
city: Gyor
country: Hungary
facility: Peregrine Pharmaceuticals Investigational Site
city: Gyula
country: Hungary
facility: Peregrine Pharmaceuticals Investigational Site
city: Szolnok
country: Hungary
facility: Peregrine Pharmaceuticals Investigational Site
city: Torokbalint
country: Hungary
facility: Peregrine Pharmaceuticals Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Peregrine Pharmaceuticals Investigational Site
city: Meldola
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
state: Forli-Cesena
city: Lido di Camaiore
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
state: Lucca
city: Taormina
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
state: Messina
city: Monza
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
state: Monza Brianza
city: Aviano
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
state: Pordenone
city: Bergamo
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
city: Cremona
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
city: Genova
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
city: Milan
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
city: Turin
country: Italy
facility: Peregrine Pharmaceuticals Investigational Site
city: Suwon
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
state: Gyonggi-do
city: Busan
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
city: Cheongju-si
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
city: Incheon
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
city: Seongnam
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
city: Seoul
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
city: Seoul
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
city: Seoul
country: Korea, Republic of
facility: Peregrine Pharmaceuticals Investigational Site
city: Brasov
country: Romania
facility: Peregrine Pharmaceuticals Investigational Site
city: Cluj-Napoca
country: Romania
facility: Peregrine Pharmaceuticals Investigational Site
city: Cluj-Napoca
country: Romania
facility: Peregrine Pharmaceuticals Investigational Site
city: Ploiesti
country: Romania
facility: Peregrine Pharmaceuticals Investigational Site
city: Suceava
country: Romania
facility: Peregrine Pharmaceuticals Investigational Site
city: Turda
country: Romania
facility: Peregrine Pharmaceuticals Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Peregrine Pharmaceuticals Investigational Site
city: Kursk
country: Russian Federation
facility: Peregrine Pharmaceuticals Investigational Site
city: Nizhny Novgorod
country: Russian Federation
facility: Peregrine Pharmaceuticals Investigational Site
city: Obninsk
country: Russian Federation
facility: Peregrine Pharmaceuticals Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Peregrine Pharmaceuticals Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Peregrine Pharmaceuticals Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Peregrine Pharmaceuticals Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Peregrine Pharmaceuticals Investigational Site
city: Badalona
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
state: Barcelona
city: Manresa
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
state: Barcelona
city: Majadahonda
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
state: Madrid
city: Pamplona
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
state: Navarra
city: A Coruna
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Barcelona
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Barcelona
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Barcelona
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Madrid
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Madrid
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Madrid
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Madrid
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Malaga
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Valencia
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Valencia
country: Spain
facility: Peregrine Pharmaceuticals Investigational Site
city: Kaohsiung City
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Putzu
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Taichung
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Taichung
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Tainan City
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Tainan
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Taipei
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Taipei
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Taipei
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Taoyuan
country: Taiwan
facility: Peregrine Pharmaceuticals Investigational Site
city: Chernivtsi
country: Ukraine
facility: Peregrine Pharmaceuticals Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Peregrine Pharmaceuticals Investigational Site
city: Khmelnytskyi
country: Ukraine
facility: Peregrine Pharmaceuticals Investigational Site
city: Kyiv
country: Ukraine
facility: Peregrine Pharmaceuticals Investigational Site
city: Lutsk
country: Ukraine
facility: Peregrine Pharmaceuticals Investigational Site
city: Uzhgorod
country: Ukraine
facility: Peregrine Pharmaceuticals Investigational Site
Study officials:
References:
citation: 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.