A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
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)
2 other identifiers
interventional
130
8 countries
93
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2010
CompletedFirst Posted
Study publicly available on registry
October 11, 2010
CompletedStudy Start
First participant enrolled
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
August 20, 2020
CompletedAugust 20, 2020
March 1, 2018
1.5 years
October 7, 2010
March 15, 2018
August 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of the first observation of investigator-assessed (radiology review) progression based on Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 or other protocol-approved measures of disease progression (e.g., new occurrence of positive fluid cytology, newly diagnosed evidence of disease progression from histologic samples, PET-positive metastases, or new bone or brain metastases), or date of death, whatever the cause. Disease progression as assessed by the investigator per RECIST v1.0 was defined as at least a 20% increase in sum of longest diameters (RECIST definition) compared to baseline (or lowest sum while on study if less than baseline), or any new lesions (measurable or nonmeasurable).
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 (4)
Overall Response Rate (ORR)
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
Duration of Response (DR)
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
Overall Survival (OS)
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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
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
Study Arms (2)
Farletuzumab plus Chemotherapy
ACTIVE COMPARATORDuring Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression.
Placebo plus Chemotherapy
PLACEBO COMPARATORDuring Combination Therapy, placebo will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive placebo as monotherapy until disease progression.
Interventions
Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles. Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression.
Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles. Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression.
Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL\^min \[AUC5-6\].
Paclitaxel 200 mg/m\^2 will be administered intravenously.
Pemetrexed 500 mg/m\^2 will be administered intravenously.
Cisplatin 75 mg/m\^2 will be administered intravenously.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morphoteklead
Study Sites (93)
Ironwood Cancer and Research Center
Chandler, Arizona, 85224, United States
Arizona Center for Hematology Oncology
Glendale, Arizona, 85306-4666, United States
Providence Health System
Beverly Hills, California, 90210-5501, United States
Cancer Care Associates of Fresno Medical Group, Inc.
Fresno, California, 93720, United States
Medical Oncology Hematology
Gilroy, California, 95020, United States
California Cancer Care, Inc.
Greenbrae, California, 94904, United States
Moores University of California San Diego Cancer Center
La Jolla, California, 92093, United States
Wilshire Medical Oncology Group
La Verne, California, 91750, United States
Glendale Adventist Medical Center
Los Angeles, California, 90025, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
North Country Oncology-Hematology
Oceanside, California, 92056, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
Central Coast Medical Oncology
Santa Maria, California, 93454, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218-1237, United States
Hematology Oncology Associates, P.C.
Stamford, Connecticut, 06902-3628, United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486, United States
Medical Specialists of the Palm Beaches
Deerfield Beach, Florida, 33441, United States
Broward General Medical Center
Fort Lauderdale, Florida, 33316, United States
Cancer Care of North Florida
Lake City, Florida, 32024, United States
Florida Cancer Institute-New Hope
New Port Richey, Florida, 34655, United States
Ocala Oncology Center, PL
Ocala, Florida, 34474, United States
MD Anderson Cancer Center-Orlando
Orlando, Florida, 32806, United States
University Hematology Oncology, Inc.
Centralia, Illinois, 62801, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
The Community Hospital
Munster, Indiana, 46321, United States
Kentucky Cancer Center
Hazard, Kentucky, 41701, United States
Baptist Health System, Inc.
Lexington, Kentucky, 40503, United States
Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center
Alexandria, Louisiana, 71301, United States
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, 70006, United States
National Cancer Institute
Bethesda, Maryland, 20892, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, 01201, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, 48336, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Queens Hospital Center
Jamaica, New York, 11432, United States
Syracuse Veterns Affairs Medical Center
Syracuse, New York, 13210, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
St. Luke's Cancer Center Associates
Bethlehem, Pennsylvania, 18015, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Texas Oncology - Bedford
Bedford, Texas, 76022, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Houston Cancer Institute
Houston, Texas, 77055, United States
Texas Oncology - Plano East
Plano, Texas, 75075-7787, United States
Northwest Cancer Center
Sugar Land, Texas, 77479, United States
Texas Oncology - Tyler
Tyler, Texas, 75702-8363, United States
Texas Oncology - Waco
Waco, Texas, 76712, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Delta Hematology Oncology Associates, PC
Portsmouth, Virginia, 23704, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Rockwood Cancer Treatment Center
Spokane, Washington, 99204, United States
Medical Oncology Associates, PS
Spokane, Washington, 99208, United States
Cancer Team Bellin Health
Green Bay, Wisconsin, 54313, United States
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Southern Medical Day Oncology Care Centre
Wollongong, New South Wales, 2500, Australia
Royal Brisbane and Women's Hospital, Dept. of Medical Oncology
Brisbane, Queensland, 4029, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital, Cancer Centre
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre, Dept. of Oncology
Bedford Park, South Australia, 5042, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Frankston Hospital, Oncology Day Unit
Frankston, Victoria, 3199, Australia
Epworth Healthcare
Richmond, Victoria, 3002, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3, Canada
Princess Margaret Hospital
Toronto, Ontario, MSG 2L7, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69126, Germany
Klinik Löwenstein gGmbH
Löwenstein, Baden-Wurttemberg, 74245, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Bavaria, 82131, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, 60488, Germany
Johannes-Wesling-Klinikum Minden
Minden, North Rhine-Westphalia, 32429, Germany
Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH
Halle, Saxony-Anhalt, 06120, Germany
HELIOS Klinikum Emil von Behring
Berlin, 14165, Germany
Asklepios Klinik Harburg
Hamburg, 21075, Germany
Ospedale Unico Versilia
Lido di Camaiore, Lucca, 55043, Italy
Azienda Ospedaliero-Univesitaria "San Luigi Gonzaga"
Orbassano, Torino, 10043, Italy
Istituto Nazionale per la Ricerca sul Cancro
Genova, 16132, Italy
A.O. Seconda Università degli Studi di Napoli
Napoli, 80131, Italy
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
Warsaw, Masovian Voivodeship, 02-781, Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Szczecin, West Pomeranian Voivodeship, 70-891, Poland
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan', Tatarstan Republic, 420029, Russia
Cancer Research Center n.a. N.N. Blokhin
Moscow, 115478, Russia
City Oncology Hospital # 62
Moscow, 143423, Russia
Hospital Regional Carlos Haya
Málaga, Malaga, 29010, Spain
Hospital General Vall d'Hebron, Barcelona
Barcelona, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Germans Trías i Pujol
Barcelona, 08916, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Morphotek (subsidiary of Eisai)
- Organization
- Morphotek (subsidiary of Eisai)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2010
First Posted
October 11, 2010
Study Start
June 27, 2011
Primary Completion
December 15, 2012
Study Completion
November 1, 2013
Last Updated
August 20, 2020
Results First Posted
August 20, 2020
Record last verified: 2018-03