Clinical trial NCT01218516: A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum-Containing Doublet in Chemotherapy-Naive Subjects With Stage IV Adenocarcinoma of the Lung (FLAIR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Lung
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2010-10-11
Enrollment: 130
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 objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV
* Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)
* Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo)
* Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung

Exclusion Criteria:

* Participants who have had previous chemotherapy for adenocarcinoma of the lung
* Prior surgery with curative intent for adenocarcinoma of the lung
* Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control \[i.e., palliative radiation with non-curative intent\] is permitted)

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysis
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
measure: Duration of Response (DR)
timeFrame: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
measure: Overall Survival (OS)
timeFrame: From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 28 months) for final analysis
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
timeFrame: For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Glendale
country: United States
facility: Arizona Center for Hematology Oncology
state: Arizona
city: Beverly Hills
country: United States
facility: Providence Health System
state: California
city: Fresno
country: United States
facility: Cancer Care Associates of Fresno Medical Group, Inc.
state: California
city: Gilroy
country: United States
facility: Medical Oncology Hematology
state: California
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: La Jolla
country: United States
facility: Moores University of California San Diego Cancer Center
state: California
city: La Verne
country: United States
facility: Wilshire Medical Oncology Group
state: California
city: Los Angeles
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Oceanside
country: United States
facility: North Country Oncology-Hematology
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Stamford
country: United States
facility: Hematology Oncology Associates, P.C.
state: Connecticut
city: Boca Raton
country: United States
facility: Center for Hematology-Oncology
state: Florida
city: Deerfield Beach
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Lake City
country: United States
facility: Cancer Care of North Florida
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute-New Hope
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center, PL
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center-Orlando
state: Florida
city: Centralia
country: United States
facility: University Hematology Oncology, Inc.
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Munster
country: United States
facility: The Community Hospital
state: Indiana
city: Hazard
country: United States
facility: Kentucky Cancer Center
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health System, Inc.
state: Kentucky
city: Alexandria
country: United States
facility: Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center
state: Louisiana
city: Metairie
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Bethesda
country: United States
facility: National Cancer Institute
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology, PC
state: Massachusetts
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: Syracuse
country: United States
facility: Syracuse Veterns Affairs Medical Center
state: New York
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Cancer Center Associates
state: Pennsylvania
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Houston Cancer Institute
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano East
state: Texas
city: Sugar Land
country: United States
facility: Northwest Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Portsmouth
country: United States
facility: Delta Hematology Oncology Associates, PC
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Rockwood Cancer Treatment Center
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates, PS
state: Washington
city: Green Bay
country: United States
facility: Cancer Team Bellin Health
state: Wisconsin
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Oncology Care Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital, Dept. of Medical Oncology
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital, Cancer Centre
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre, Dept. of Oncology
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital, Oncology Day Unit
state: Victoria
city: Richmond
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-wuerttemberg
city: Löwenstein
country: Germany
facility: Klinik Löwenstein gGmbH
state: Baden-wuerttemberg
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest GmbH
state: Hessen
city: Minden
country: Germany
facility: Johannes-Wesling-Klinikum Minden
state: Nordrhein-westfalen
city: Halle
country: Germany
facility: Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH
state: Sachsen-anhalt
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Lido di Camaiore
country: Italy
facility: Ospedale Unico Versilia
state: Lucca
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Univesitaria "San Luigi Gonzaga"
state: Torino
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro
city: Napoli
country: Italy
facility: A.O. Seconda Università degli Studi di Napoli
city: Torun
country: Poland
facility: Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
state: Mazowieckie
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego
state: Zachodniopomorskie
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
state: Tatarstan
city: Moscow
country: Russian Federation
facility: Cancer Research Center n.a. N.N. Blokhin
city: Moscow
country: Russian Federation
facility: City Oncology Hospital # 62
city: Málaga
country: Spain
facility: Hospital Regional Carlos Haya
state: Malaga
city: Barcelona
country: Spain
facility: Hospital General Vall d'Hebron, Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Germans Trías i Pujol
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
Study officials:
References: