Phase
Condition
Carcinoma
Cancer
Lung Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Have histologically or cytologically confirmed stage IIIB (and not a candidate fordefinitive multimodality therapy) or stage four (IV) NSCLC.
- Must have documented ALK rearrangement.
- Have sufficient tumor tissue available for central analysis.
- Have at least 1 measurable (that is, target) lesion per RECIST v1.1.
- Recovered from toxicities related to prior anticancer therapy to National CancerInstitute (of the United States) (NCI) Common Terminology Criteria for Adverse Events (version 4.0) (CTCAE v 4.0) grade be less than or equal to (<=) 1.
- Are a male or female participants greater than or equal to (>=)18 years old.
- Have adequate organ function, as defined by the study protocol.
- Have Eastern Cooperative Oncology Group (ECOG) performance status <=2.
- Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of <= 450 millisecond (msec) in males or <=470 msec in females.
- For female participants of childbearing potential, have a negative pregnancy testdocumented prior to randomization.
- For female and male participants who are fertile, agree to use a highly effective formof contraception, as defined by the study protocol.
- Provide signed and dated informed consent indicating that the participants has beeninformed of all pertinent aspects of the study, including the potential risks, and iswillingly participating.
- Have the willingness and ability to comply with scheduled visit and study procedures.
Exclusion
Exclusion Criteria:
- Previously received an investigational antineoplastic agent for NSCLC.
- Previously received any prior tyrosine kinase inhibitor (TKI), including ALK-targetedTKIs.
- Previously received more than 1 regimen of systemic anticancer therapy for locallyadvanced or metastatic disease.
- Received chemotherapy or radiation within 14 days of first dose of study drug, exceptstereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT).
- Received anti-neoplastic monoclonal antibodies within 30 days of the first dose ofstudy drug.
- Had major surgery within 30 days of the first dose of study drug, minor surgicalprocedures such as catheter placement or minimally invasive biopsies are allowed.
- Have been diagnosed with another primary malignancy other than NSCLC, except foradequately treated non-melanoma skin cancer or cervical cancer in situ; definitivelytreated non-metastatic prostate cancer; or participants with another primarymalignancy who are definitively relapse-free with at least 3 years elapsed since thediagnosis of the other primary malignancy.
- Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening orasymptomatic disease requiring an increasing dose of corticosteroids to controlsymptoms within 7 days prior to randomization.
- Have current spinal cord compression (symptomatic or asymptomatic and detected byradiographic imaging). Participants with leptomeningeal disease and without cordcompression are allowed.
- Be pregnant, planning a pregnancy, or breastfeeding.
- Have significant, uncontrolled, or active cardiovascular disease, as defined by thestudy protocol.
- Have uncontrolled hypertension.
- Have a history or the presence at baseline of pulmonary interstitial disease,drug-related pneumonitis, or radiation pneumonitis.
- Have an ongoing or active infection.
- Have a known history of human immunodeficiency virus (HIV) infection.
- Have a known or suspected hypersensitivity to brigatinib or its excipients and/orcrizotinib or its excipients.
- Have malabsorption syndrome or other gastrointestinal (GI) illness or condition.
- Have any condition or illness that, in the opinion of the investigator, wouldcompromise participant's safety or interfere with the evaluation of the study drug.
Study Design
Study Description
Connect with a study center
St Vincent's Hospital, Pharmacy, Site #406
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Gosford Hospital Central Coaast Cancer Centre, Site #402
Gosford, New South Wales 2250
AustraliaSite Not Available
Saint George Hospital
Kogarah, New South Wales 2217
AustraliaSite Not Available
Royal North Shore Hospital
St Leonards, New South Wales 2065
AustraliaSite Not Available
Monash Medical Centre
Bentleigh East, Victoria 3165
AustraliaSite Not Available
Monash Medical Centre
East Bentleigh, Victoria 3165
AustraliaSite Not Available
Saint Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaSite Not Available
Frankston Hospital, Site #994
Frankston, Victoria 3199
AustraliaSite Not Available
Universitatsklinium St. Polten
Sankt Polten, Lower Austria 3100
AustriaSite Not Available
Salzburger Landeskliniken University Clinic for Pneumology
Salzburg, 5020
AustriaSite Not Available
Universitatsklinikum St. Polten (Site 462)
St. Polten, 3100
AustriaSite Not Available
Otto-Wagner-Spital Baumgartner Hohe
Vienna, 1140
AustriaSite Not Available
Klinikum Wels-Grieskirchen, Site #461
Wels, 4600
AustriaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Odense University Hospital (Site 615)
Odense, 5000
DenmarkSite Not Available
Odense University Hospital
Odense C, 5000
DenmarkSite Not Available
Tampere University Hospital Pharmacy, Site #467
Tampere, 33520
FinlandSite Not Available
Centre de Lutte Contre le Cancer Francois Baclesse
CAEN Cedex 5, Basse-normandie 14076
FranceSite Not Available
Centre Francois Baclesse (Site 568)
Caen, Cedex 05 14076
FranceSite Not Available
Hopital Charles Nicolle
Rouen, Haute-normandie 76041
FranceSite Not Available
Centre Hospitalier Intercommunal de Creteil
Creteil, Ile-de-france 94010
FranceSite Not Available
Hopital Tenon
Paris, Ile-de-france 75020
FranceSite Not Available
Centre Hospitalier Universitaire Hopital Nord
Marseille Cedex 20, Provence Alpes COTE D'azur 13915
FranceSite Not Available
Hopital Albert Michallon
Grenoble Cedex 9, Rhone-alpes 38043
FranceSite Not Available
Centre Leon Berard
Lyon, Rhone-alpes 69008
FranceSite Not Available
CHRU de Brest - Hopital Morvan (Site 523)
Brest, 29200
FranceSite Not Available
CHU de Grenoble - Hopital Albert Michallon (Site 569)
Grenoble, 38043
FranceSite Not Available
Hopital Nord, Pharmacie (Site 567)
Marseille, 13015
FranceSite Not Available
Centre Antoine Lacassagne (Site 570)
Nice, 06189
FranceSite Not Available
Nouvel Hopital Civil
Strasbourg, 67091
FranceSite Not Available
Universitatsklinik Freiburg
Freiburg, Baden-wuerttemberg 79106
GermanySite Not Available
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-wuerttemberg 69126
GermanySite Not Available
Klinikum der Ludwig-Maximilian-Universitat Munchen (Site 609)
Munchen, Bayern 80336
GermanySite Not Available
Pius Hospital Oldenburg
Oldenburg, Niedersachsen 26121
GermanySite Not Available
Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim
Koln, Nordrhein-westfalen 51109
GermanySite Not Available
Evangelische Lungenklinik Berlin
Berlin, 13125
GermanySite Not Available
Hospital for Lung Disease Cologne Merheim Site #626
Cologne, 51100
GermanySite Not Available
Studiengesellschaft Haemato-Onkologie Hamburg Prof. Laack und Partner
Hamburg, 20251
GermanySite Not Available
Lungenklinik Hemer, Site #620
Hemer, 58675
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein, Site #472
Kiel, 24105
GermanySite Not Available
Studiengesellschaft Hamato-Onkologie Hamburg (Site 473)
Oststeinbek, 22113
GermanySite Not Available
Tuen Mun Hospital
Tuen Mun, New Territories
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Queen Elizabeth Hospital
Kowloon, 150001
Hong KongSite Not Available
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-cesena 47014
ItalySite Not Available
Azienda Ospedaliera San Gerardo di Monza
Monza, Monza E Brianza 20052
ItalySite Not Available
Centro di Riferimento Oncologico di Aviano
Aviano, Pordenone 33081
ItalySite Not Available
AOU Policlinico - Vittorio Emanuele (Site 475)
Catania, Sicily 95123
ItalySite Not Available
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100
ItalySite Not Available
Istituto Oncologico di Bari Giovanni Paolo II
Bari, 70124
ItalySite Not Available
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, 40138
ItalySite Not Available
Istituto Europeo di Oncologia
Milano, 20141
ItalySite Not Available
Istituto Scientifico Universitario San Raffaele
Milano, 20132
ItalySite Not Available
Istituto Tumori Napoli Fondazione G. Pascale
Napoli, 80131
ItalySite Not Available
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, 28100
ItalySite Not Available
Oncologia Medica Azienda Ospedaliera - Universitaria di Parma (Site 607)
Parma, 43126
ItalySite Not Available
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
Perugia, 06132
ItalySite Not Available
Azienda Unita Sanitaria Locale di Ravenna
Ravenna, 48121
ItalySite Not Available
Policlinico Universitario Campus Bio-Medico
Roma, 00128
ItalySite Not Available
Chungbuk National University Hospital
Cheongju, Chungcheongbuk-do 28644
Korea, Republic ofSite Not Available
National Cancer Center
Goyang-si, Gyeonggi-do 10408
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
Korea, Republic ofSite Not Available
Severence Hospital, Yonsei University Health System, Site # 913
Seodaemun-gu, Seoul 03722
Korea, Republic ofSite Not Available
National Cancer Center, Center for Lung Cancer, Site #916
Ilsan, 10408
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital, Site #408
Seongnam, 463-707
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea
Seoul, 06591
Korea, Republic ofSite Not Available
Chungbuk National University Hospital, Site #407
Seowon, 28644
Korea, Republic ofSite Not Available
Centre Hospitalier de Luxembourg - Hopital Municipal
Luxembourg, 1210
LuxembourgSite Not Available
Amphia Ziekenhuis - Locatie Langendijk Breda
Breda, Noord-brabant 4818 CK
NetherlandsSite Not Available
Antoni van Leeuwenhoekziekenhuis
Amsterdam, Noord-holland 1066 CX
NetherlandsSite Not Available
Isala Klinieken
Zwolle, Overijssel 8025 AB
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsSite Not Available
Radiumhospitalet
Oslo, 0379
NorwaySite Not Available
National Cancer Centre Singapore
Singapore, 169610
SingaporeSite Not Available
National University Hospital
Singapore, 119228
SingaporeSite Not Available
OncoCare Cancer Centre
Singapore, 258499
SingaporeSite Not Available
Hospital Universitario Central de Asturias
Oviedo, Asturias 33011
SpainSite Not Available
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona 08916
SpainSite Not Available
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid 28222
SpainSite Not Available
Hospital Clinico Universitario Virgen de la Arrixaca (Site 491)
El Palmar, Murcia 30120
SpainSite Not Available
Hospital Teresa Herrera Site #554
A Coruna, 15006
SpainSite Not Available
Hospital General Universitario de Alicante
Alicante, 03010
SpainSite Not Available
Hospital de Cruces
Baracaldo, 48903
SpainSite Not Available
Hospital Universitario Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Teresa Herrera - Materno Infantil
La Coruna, 15006
SpainSite Not Available
Hospital Universitario Lucus Augusti (Site 488)
Lugo, 27003
SpainSite Not Available
Hospital Ramon Y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Regional Universitario Carlos Haya Malaga Instituto de Neurociencias Clinicas
Malaga, 29010
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander, 39008
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
Sahlgrenska Universitetssjukhuset (Site 758)
Molnlycke, SE-435 33
SwedenSite Not Available
Karolinska Hospital, Site #763
Solna, 17164
SwedenSite Not Available
Karolinska Universitetssjukhuset
Stockholm, 171 76
SwedenSite Not Available
University Hospital of Umeå (Site 495)
Umea, 90737
SwedenSite Not Available
Kantonsspital Winterthur (Site 995)
Winterthur, 8401
SwitzerlandSite Not Available
University Hospital Zurich
Zurich, 8091
SwitzerlandSite Not Available
Taichung Veterans General Hospital (Site 410)
Xitun, Taichung 407
TaiwanSite Not Available
National Cheng Kung University
Tainan, Taipei 70403
TaiwanSite Not Available
China Medical University Hospital
Taichung, 404
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
National Taiwan University Hospital (Site 412)
Taipei City, 100
TaiwanSite Not Available
Leicester Royal Infirmary
Leicester, England LE1 5WW
United KingdomSite Not Available
Guy's and Saint Thomas' NHS Foundation Trust
London, England SE1 9RT
United KingdomSite Not Available
Royal Marsden NHS Trust
London, England SW3 6JJ
United KingdomSite Not Available
University College London
London, England NW1 2PG
United KingdomSite Not Available
Maidstone Hospital
Maidstone, England ME16 9QQ
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester, England M20 4BX
United KingdomSite Not Available
USOR - Arizona Oncology Associates - Sedona
Sedona, Arizona 86336
United StatesSite Not Available
Kaiser Permanente Bellflower Medical Offices
Bellflower, California 90706
United StatesSite Not Available
Kaiser Permanente Southern California, Site #208
San Diego, California 92120
United StatesSite Not Available
Innovative Clinical Research Institute (Site 243)
Whittier, California 90603
United StatesSite Not Available
University of Colorado Cancer Center
Aurora, Colorado 80045
United StatesSite Not Available
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado 80303-1385
United StatesSite Not Available
Yale Cancer Center, Site #033
New Haven, Connecticut 06510
United StatesSite Not Available
Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida 33442
United StatesSite Not Available
University of Miami Sylvester Comprehensive Cancer Center, Site #241
Miami, Florida 33136
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United StatesSite Not Available
Minnesota Oncology
Coon Rapids, Minnesota 55433
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10461
United StatesSite Not Available
Montefiore Medical Center, Site #038
The Bronx, New York 10461
United StatesSite Not Available
Novant Presbyterian Medical Center (Site 205)
Charlotte, North Carolina 28204
United StatesSite Not Available
Oncology Hematology Care - Blue Ash
Cincinnati, Ohio 45242-5665
United StatesSite Not Available
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Arizona Oncology Associates (Site 244)
Fort Worth, Texas 76177
United StatesSite Not Available
The University of Texas M D Anderson Cancer Center (Site 005)
Houston, Texas 77030
United StatesSite Not Available
Huntsman Cancer Institute (Site 043)
Salt Lake City, Utah 84112
United StatesSite Not Available
Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia 22031
United StatesSite Not Available

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