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A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

Primary Purpose

Adenocarcinoma of the Lung

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Farletuzumab
Placebo
Carboplatin
Paclitaxel
Pemetrexed
Cisplatin
Sponsored by
Morphotek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ironwood Cancer and Research Center
  • Arizona Center for Hematology Oncology
  • Providence Health System
  • Cancer Care Associates of Fresno Medical Group, Inc.
  • Medical Oncology Hematology
  • California Cancer Care, Inc.
  • Moores University of California San Diego Cancer Center
  • Wilshire Medical Oncology Group
  • Glendale Adventist Medical Center
  • Clinical Trials and Research Associates, Inc.
  • North Country Oncology-Hematology
  • Pacific Hematology Oncology Associates
  • Central Coast Medical Oncology
  • Rocky Mountain Cancer Centers, LLP
  • Hematology Oncology Associates, P.C.
  • Center for Hematology-Oncology
  • Medical Specialists of the Palm Beaches
  • Broward General Medical Center
  • Cancer Care of North Florida
  • Florida Cancer Institute-New Hope
  • Ocala Oncology Center, PL
  • MD Anderson Cancer Center-Orlando
  • University Hematology Oncology, Inc.
  • University of Chicago Medical Center
  • Deaconess Clinic Downtown
  • The Community Hospital
  • Kentucky Cancer Center
  • Baptist Health System, Inc.
  • Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center
  • Hematology and Oncology Specialists, LLC
  • National Cancer Institute
  • Maryland Oncology Hematology, P.A.
  • Berkshire Hematology Oncology, PC
  • Detroit Clinical Research Center
  • Englewood Hospital and Medical Center
  • Queens Hospital Center
  • Syracuse Veterns Affairs Medical Center
  • Willamette Valley Cancer Institute and Research Center
  • St. Luke's Cancer Center Associates
  • Gettysburg Cancer Center
  • Tennessee Oncology, PLLC
  • Texas Oncology - Bedford
  • University of Texas Medical Branch
  • Houston Cancer Institute
  • Texas Oncology - Plano East
  • Northwest Cancer Center
  • Texas Oncology - Tyler
  • Texas Oncology - Waco
  • Virginia Cancer Specialists, PC
  • Delta Hematology Oncology Associates, PC
  • Virginia Mason Medical Center
  • Rockwood Cancer Treatment Center
  • Medical Oncology Associates, PS
  • Cancer Team Bellin Health
  • The Tweed Hospital
  • Southern Medical Day Oncology Care Centre
  • Royal Brisbane and Women's Hospital, Dept. of Medical Oncology
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital, Cancer Centre
  • Flinders Medical Centre, Dept. of Oncology
  • Lyell McEwin Hospital
  • The Queen Elizabeth Hospital
  • Box Hill Hospital
  • Frankston Hospital, Oncology Day Unit
  • Epworth Healthcare
  • Fremantle Hospital
  • Royal Victoria Hospital
  • Grand River Regional Cancer Centre
  • Princess Margaret Hospital
  • Jewish General Hospital
  • Universitätsklinikum Heidelberg
  • Klinik Löwenstein gGmbH
  • Asklepios Fachkliniken München-Gauting
  • Krankenhaus Nordwest GmbH
  • Johannes-Wesling-Klinikum Minden
  • Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH
  • HELIOS Klinikum Emil von Behring
  • Asklepios Klinik Harburg
  • Ospedale Unico Versilia
  • Azienda Ospedaliero-Univesitaria "San Luigi Gonzaga"
  • Istituto Nazionale per la Ricerca sul Cancro
  • A.O. Seconda Università degli Studi di Napoli
  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy
  • Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
  • Specjalistyczny Szpital im. Alfreda Sokolowskiego
  • Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
  • Cancer Research Center n.a. N.N. Blokhin
  • City Oncology Hospital # 62
  • Hospital Regional Carlos Haya
  • Hospital General Vall d'Hebron, Barcelona
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Germans Trías i Pujol
  • Fundación Jiménez Díaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Farletuzumab plus Chemotherapy

Placebo plus Chemotherapy

Arm Description

During 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.

During 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Overall Response Rate (ORR)
ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator's radiologic assessments using RECIST 1.1 for target lesions and assessed by Magnetic resonance imaging (MRI) and computerized tomography (CT) scan (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Duration of Response (DR)
DR was derived for those participants with objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression (ie, objective tumor progression as assessed by investigator's radiology review or other protocol-approved measures of disease progression) or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Overall Survival (OS)
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of cause.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the participant was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, TEAEs (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

Full Information

First Posted
October 7, 2010
Last Updated
August 10, 2020
Sponsor
Morphotek
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1. Study Identification

Unique Protocol Identification Number
NCT01218516
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 27, 2011 (Actual)
Primary Completion Date
December 15, 2012 (Actual)
Study Completion Date
November 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morphotek

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Farletuzumab plus Chemotherapy
Arm Type
Active Comparator
Arm Description
During 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.
Arm Title
Placebo plus Chemotherapy
Arm Type
Placebo Comparator
Arm Description
During 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.
Intervention Type
Biological
Intervention Name(s)
Farletuzumab
Other Intervention Name(s)
MORAb-003
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL^min [AUC5-6].
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 200 mg/m^2 will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed 500 mg/m^2 will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 75 mg/m^2 will be administered intravenously.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator's radiologic assessments using RECIST 1.1 for target lesions and assessed by Magnetic resonance imaging (MRI) and computerized tomography (CT) scan (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Time Frame
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
Title
Duration of Response (DR)
Description
DR was derived for those participants with objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression (ie, objective tumor progression as assessed by investigator's radiology review or other protocol-approved measures of disease progression) or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame
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
Title
Overall Survival (OS)
Description
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of cause.
Time Frame
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
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Description
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the participant was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, TEAEs (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Ironwood Cancer and Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Center for Hematology Oncology
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306-4666
Country
United States
Facility Name
Providence Health System
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210-5501
Country
United States
Facility Name
Cancer Care Associates of Fresno Medical Group, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Medical Oncology Hematology
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Moores University of California San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Wilshire Medical Oncology Group
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Clinical Trials and Research Associates, Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
North Country Oncology-Hematology
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Central Coast Medical Oncology
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Rocky Mountain Cancer Centers, LLP
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1237
Country
United States
Facility Name
Hematology Oncology Associates, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902-3628
Country
United States
Facility Name
Center for Hematology-Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Medical Specialists of the Palm Beaches
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33441
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Cancer Care of North Florida
City
Lake City
State/Province
Florida
ZIP/Postal Code
32024
Country
United States
Facility Name
Florida Cancer Institute-New Hope
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Ocala Oncology Center, PL
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
MD Anderson Cancer Center-Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University Hematology Oncology, Inc.
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Deaconess Clinic Downtown
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
The Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Kentucky Cancer Center
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Baptist Health System, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Hematology and Oncology Specialists, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
National Cancer Institute
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Berkshire Hematology Oncology, PC
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Detroit Clinical Research Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Queens Hospital Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Syracuse Veterns Affairs Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
St. Luke's Cancer Center Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Houston Cancer Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Texas Oncology - Plano East
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7787
Country
United States
Facility Name
Northwest Cancer Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702-8363
Country
United States
Facility Name
Texas Oncology - Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Delta Hematology Oncology Associates, PC
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Rockwood Cancer Treatment Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Medical Oncology Associates, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Cancer Team Bellin Health
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54313
Country
United States
Facility Name
The Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Southern Medical Day Oncology Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital, Dept. of Medical Oncology
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital, Cancer Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre, Dept. of Oncology
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Frankston Hospital, Oncology Day Unit
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Epworth Healthcare
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Grand River Regional Cancer Centre
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
MSG 2L7
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-wuerttemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Klinik Löwenstein gGmbH
City
Löwenstein
State/Province
Baden-wuerttemberg
ZIP/Postal Code
74245
Country
Germany
Facility Name
Asklepios Fachkliniken München-Gauting
City
Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
Facility Name
Krankenhaus Nordwest GmbH
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
Facility Name
Johannes-Wesling-Klinikum Minden
City
Minden
State/Province
Nordrhein-westfalen
ZIP/Postal Code
32429
Country
Germany
Facility Name
Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH
City
Halle
State/Province
Sachsen-anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
HELIOS Klinikum Emil von Behring
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Asklepios Klinik Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Ospedale Unico Versilia
City
Lido di Camaiore
State/Province
Lucca
ZIP/Postal Code
55043
Country
Italy
Facility Name
Azienda Ospedaliero-Univesitaria "San Luigi Gonzaga"
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Seconda Università degli Studi di Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Specjalistyczny Szpital im. Alfreda Sokolowskiego
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Cancer Research Center n.a. N.N. Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Oncology Hospital # 62
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Hospital Regional Carlos Haya
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital General Vall d'Hebron, Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Germans Trías i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

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A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

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