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

Non-Small Cell Lung Cancer Clinical Trial

— SUNRISE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999673
• Other study ID #: PPHM 1202
• Secondary ID: 2013-003953-13
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2013
• Last updated: April 19, 2017
• Start date: December 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Non-Small-Cell Lung Cancer Metastatic
• Non-Small-Cell Lung Cancer Stage IIIB
• Non-Small-Cell Lung Cancer Stage IV
• Non-Small-Cell Lung Carcinoma
• Nonsmall Cell Lung Cancer

Intervention

Biological:
• bavituximab

Drug:
• Docetaxel

Other:
• Placebo (for bavituximab)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Romania,  Russian Federation,  Spain,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Approximately up to 36 months
Secondary	Progression-free survival		Approximately up to 36 months
Secondary	Overall Response Rate		Approximately up to 36 months
Secondary	Safety	As measured by adverse event rates and laboratory evaluations	Approximately up to 36 months