Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer (FORTIS-M)
Non Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Talactoferrin, Dendritic Cell Recruiter and Activator, Immunomodulatory agent
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed stage IIIB or IV NSCLC
- Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
- At least one target lesion that is unirradiated and measurable by RECIST
- Adequate hematologic, renal and hepatic function
- ECOG 0, 1, or 2
- Able to understand and sign an Informed Consent
Exclusion Criteria:
- Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
- Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
- History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
- Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
- Serious active infection
- Psychiatric illness/ social situations that would limit study compliance
- Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
- Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
- Known HIV positive or on active anti-retroviral therapy
- Known Hepatitis B surface antigen positive or hepatitis C positive
- Receipt of any investigational medication within 4 weeks prior to randomization
- Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
- Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
- Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
Sites / Locations
- Desert Oasis Cancer Center
- Arizona Oncology Associates
- University of Colorado Hospital
- Pasco Pinellas Cancer Center
- Emory University
- Rush University Medical Center
- Cancer Care Specialists of Central Illinois
- Cancer Care & Hematology Specialists of Chicagoland
- Central Indiana Cancer Centers
- Kansas City Cancer Center, LLC
- NCI, CCR, The Waren Grant Magnuson Clinical Center
- Newland Medical Associates
- Minnesota Oncology and Hematology, PA
- Washington University School of Medicine
- Southeast Nebraska Cancer Center
- NH Oncology-Hematology, PA
- Montefiore Medical Center
- University of Rochester Medical Center
- Alamance Regional Medical Center
- Duke University Medical Center
- Rex Cancer Center
- Legacy Pharma Research
- Signal Point Clinical Research Center
- Kaiser Group Health
- Texas Oncology
- Texas Oncology
- Tyler Cancer Center
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
- Cancer Care Northwest
- Campbelltown Hospital
- Port Macquarie Base Hospital
- Townsville Hospital
- The Queen Elisabeth Hospital
- Epworth Healthcare
- DDODIU-Plovdiv, EOOD
- UMHAT 'Dr. Georgi Stranski', EAD
- DDODIU-Plovdiv, EOOD
- DDODIU - Sofia District EOOD
- UMHAT 'Tsaritsa Yoanna - ISUL', EAD
- Cross Cancer Institute
- Mount Sinai Hospital
- Hôtel-Dieu de Lévis
- Gerald Bronfman Centre for Clinical Research in Oncology
- Fakultni nemocnice Na Bulovce
- Institut Onkologie a Rehabilitace Na Plesi
- Vitkovicka nemocnice a.s.
- Fakultni Nemocnice Ostrava
- Pardubicka krajska nemocnice, a.s.
- Fakultni Nemocnice Kralovske Vinohrady
- Fakultni nemocnice v Motole, s.p.
- Oblastni nemocnice Pribram, a.s.
- Nemocnice Tabor, a.s.
- Hopital Cardiologique, Chru Lille
- CHU Pontchaillou
- CRLCC René Gauducheau
- CLCC Paul Strauss
- Hopital Larrey
- Centre Catherine de Sienne
- CHU Angers
- Hopital Morvan
- Centre Francois Baclesse
- Centre d'Oncology de Gentilly
- Centre Hospitalier du Mans
- Centre Léon Berard
- Hopital Sainte Marguerite
- Hôpital Saint-Antoine
- Centre Hospitalier Lyon Sud
- Hopital Maison Blanche
- CHU de Nancy, Hopital de Brabois
- Praxis fuer interdisziplinaere Onkologie
- Universitaetsklinikum Mannheim
- Universitaetsklinikum Erlangen - PS
- Asklepios Fachkliniken Muenchen-Gauting
- Klinikum rechts der Isar der TU Muenchen
- Gemeinschaftspraxis fuer Haematologie Onkologie
- Universitaetsklinikum Goettingen
- St. Johannes Hospital - PS
- Krankenhaus Grosshansdorf
- Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH
- Zentralklinik Bad Berka
- Thoraxklinik-Heidelberg gGmbH
- General Hospital of Chania 'Ag. Georgios'
- University Hospital of Larissa
- University General Hospital of Patras
- General Hospital of Athens "Sotiria"
- University Hospital of Heraklio
- General Hospital of Thessaloniki "G. Papanikolaou"
- Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi
- Fejer Megyei Szent Gyorgy Korhaz
- Semmelweis Egyetem
- Orszagos Koranyi TBC es Pulmonologiai Intezet
- Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
- Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz
- Torokbalinti Tudogyogyintezet
- Zala Megyei Korhaz
- King George Hospital
- Apollo Hospital
- Indo-American Cancer Institute and Research Center
- Kidwai Institute of Oncology
- M. S. Ramaiah Memorial Hospital
- A.J. Medical College Hosptial
- Tata Memorial Hospital
- P.D. Hinduja Nat. Hospital & Med. Research Centre
- Kaushalya Medical Foundation Trust Hospital
- Cancer Care Clinic
- Shatabdi Hospital
- Deenanath Mangeshkar Hospital and Research Center
- Searoc Cancer Hospital
- Mahaveer Cancer Hospital and Research Centre
- Dr. Kamakshi Memorial Hospital Pvt Ltd
- Christian Medical College Hospital
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
- Istituto per la Ricerca e la Cura del Cancro
- Ospedale Versilia
- Istituto Nazionale Tumori
- Azienda Ospedaliera San Gerardo
- Azienda Ospedaliera San Camillo Forlanini
- Ospedale Mater Salutis
- CRO Centro di Riferimento Oncologico di Aviano
- Azienda Ospedaliera Istituti Ospitalieri di Cremona
- Chonnam National University Hwasun Hospital
- National Cancer Center
- Seoul National University Bundang Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Korea University Anam Hospital
- Asan Medical Center
- The Catholic University of Korea St. Vincent's Hospital
- Dr. Anna Levcenko GP and Internist Practice
- Piejuras Hospital
- Riga Eastern Clinical University Hospital
- P. Stradina Clinical University Hospital
- Nilai Cancer Institute (NCI Cancer Hospital)
- Lam Wah Ee Hospital
- Hospital Universiti Sains Malaysia
- Hospital Tengku Ampuan Afzan
- Manila Doctors Hospital
- Lung Center of the Philippines
- St. Luke's Medical Center
- Akademickie Centrum Kliniczne - Szpital AM w Gdansku
- Nzoz Vesalius
- Miedziowe Centrum Zdrowia S.A.
- NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
- Specjalistyczny Szpital im. Prof. A. Sokolowskiego
- Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
- Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
- Spitalul Judetean de Urgenta "Dr. Constantin Opris"
- Spitalul Judetean de Urgenta Braila
- S.C. Ianuli Med Consult S.R.L.
- Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
- Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
- Oncology Dispensary #2 of Krasnodar Region
- Arkhangelsk Regional Clinical Oncology Dispensary
- SHI Altay Regional Oncology Dispensary
- CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"
- City Clinical Hospital #1
- Perm Territorial Oncology Dispensary
- SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"
- National Cancer Centre
- Parkway Cancer Centre
- Medical Oncology Centre
- John Hopkins Singapore International Medical Centre
- H Mutua de Terrassa
- HU Virgen de las Nieves
- Fundacion Jimenez Diaz
- HGU La Paz
- Clinica Universitaria de Navarra
- Changhua Christian Hospital
- Kaohsiung Veterans General Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- Taipei Veterans General Hospital
- Chang-Gung Memorial Hospital, Linkou Branch
- Gazi University Medical Faculty
- Gaziantep University Medical Faculty
- Istanbul Bilim University Medical Fac.
- Ege University Medical Faculty
- Bristol Haematology & Oncology Centre
- Guy's & St Thomas' NHS Foundation Trust
- Christie Hospital
- Southampton General Hospital
- Castle Hill Hospital
- University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital
- Singleton Hospital
- University Hospital of North Staffordshire
- Wolverhampton New Cross Hospital
- Beatson West of Scotland Cancer Centre
- Ninewells Hospital
- University Hospital of Coventry and Warwickshire
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Talactoferrin alfa (talactoferrin or TLF, also known as recombinant human lactoferrin, rhLF or talactoferrinum alfa) is a recombinant version of the glycoprotein expressed in and purified from Aspergillus niger var. awamori. Talactoferrin is structurally and functionally similar to native human lactoferrin. The structural equivalence of talactoferrin to native human lactoferrin has been demonstrated by a comparison of the 3-dimensional structure, molecular weight, biological activity and other physicochemical properties, and is known to differ only in the nature of glycosylation.
Placebo contains the same phosphate-based buffer used as the diluent for the talactoferrin solution. In addition, the placebo will contain FD&C/EU grade dyes suitable for oral use to mimic the color of the vialed drug product.