A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
Adenocarcinoma of the Lung
About this trial
This is an interventional treatment trial for 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)
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
Active Comparator
Placebo Comparator
Farletuzumab plus Chemotherapy
Placebo plus Chemotherapy
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.