A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)

Who is this study for? Patients with ALK+ Advanced Non-Small Cell Lung Cancer
Status: Recruiting
Location: See all (114) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: Brigatinib tablets Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

• Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC.

• Must meet one of the following criteria:

• Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit or the Ventana ALK (D5F3) CDx Assay or Foundation Medicine's FoundationOne CDx.

• Have documented ALK rearrangement by a different test and be able to provide tumor sample to the central laboratory. (Note: central laboratory ALK rearrangement testing results are not required to be obtained before randomization).

• Had PD while on crizotinib, as assessed by the investigator or treating physician. (Note: crizotinib does not need to be the last therapy a participant received. The participant may have received chemotherapy as his/her last therapy).

• Treatment with crizotinib for at least 4 weeks before progression.

• Have had no other ALK inhibitor other than crizotinib.

• Have had no more than 2 prior regimens of systemic anticancer therapy (other than crizotinib) in the locally advanced or metastatic setting. Note: a systemic anticancer therapy regimen will be counted if it is administered for at least 1 complete cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if disease progression/recurrence occurred within 12 months upon completion of this neoadjuvant or adjuvant therapy. (Systemic therapy followed by maintenance therapy will be considered as one regimen if the maintenance therapy consists of a drug or drugs that were used in the regimen that immediately preceded maintenance).

• Have at least 1 measurable (that is, target) lesion per RECIST v1.1.

• Have recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE) v4.03 grade less than or equal to (<=)1. (Note: treatment-related alopecia or peripheral neuropathy that are grade greater than (>) 1 are allowed, if deemed irreversible).

• Have adequate organ function, as determined by:

• Total bilirubin <=1.5 times the upper limit of normal (ULN).

• Estimated glomerular filtration rate greater than equal to (>=) 30 milliliter per minute (mL/min)/1.73 square meter [m^2], using the modification of diet in renal disease equation.

• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <=2.5*ULN; <=5*ULN is acceptable if liver metastases are present.

• Serum lipase <=1.5*ULN.

• Platelet count >=75*10^9 per liter [/L].

• Hemoglobin >=9 gram per deciliter (g/dL).

• Absolute neutrophil count >=1.5*10^9 / L.

• Suitable venous access for study-required blood sampling (that is, including pharmacokinetic [PK] and laboratory safety tests).

Locations
United States
California
The Oncology Institute of Hope and Innovation
Active, not recruiting
Whittier
Georgia
University Cancer and Blood Center
Recruiting
Athens
New York
New York Oncology Hematology - Albany Medical Center
Recruiting
Albany
Virginia
Virginia Cancer Specialists
Recruiting
Fairfax
Other Locations
Argentina
Sanatorio Duarte Quiros
Active, not recruiting
Cordoba
Centro Oncologico Riojano Integral
Recruiting
La Rioja
Centro Para la Atencion Integral del Paciente Oncologico
Recruiting
San Miguel De Tucuman
Austria
Klinikum Klagenfurt Am Worthersee
Active, not recruiting
Klagenfurt Am Worthersee
Canada
Queen Elizabeth II Health Sciences Centre
Recruiting
Halifax
Toronto University Health Network
Recruiting
Toronto
Chile
Centro de Investigacion Clinica Bradford Hill
Recruiting
Recoleta
China
Beijing Cancer Hospital
Recruiting
Beijing
Beijing Chest Hospital
Recruiting
Beijing
Peking Union Medical College Hospital - East
Recruiting
Beijing
Peking University Cancer Hospital/Beijing Cancer Hospital
Recruiting
Beijing
The 307th Hospital of Chinese Peoples Liberation Army
Recruiting
Beijing
Jilin Provincial Cancer Hospital (Changchun Cancer Hospital)
Recruiting
Changchun
The First Affiliated Hospital of Guangzhou Medical University
Recruiting
Guangzhou
The First Affiliated Hospital, Zhejiang University
Recruiting
Hangzhou
Zhejiang Cancer Hospital
Recruiting
Hangzhou
Affiliated Tumor Hospital of Harbin Medical University - The 3rd Affiliated Hospital of HMU
Recruiting
Harbin
Shanghai Chest Hospital
Recruiting
Shanghai
Chang Gung Memorial Hospital Linkou Branch
Recruiting
Tianjin
Tianjin Medical University Cancer Institute & Hospital
Recruiting
Tianjin
Henan Cancer Hospital
Recruiting
Zhengzhou
Croatia
Fudan University Shanghai Cancer Center
Recruiting
Dubrovnik
Opca bolnica Dubrovnik
Recruiting
Dubrovnik
General Hospital Pula
Active, not recruiting
Pula
Klinicki bolnicki centar Sestre milosrdnice
Active, not recruiting
Zagreb
Klinika za Pulmologiju
Active, not recruiting
Zagreb
France
Centre Hospitalier Intercommunal de Creteil
Recruiting
Creteil
Fudan University Shanghai Cancer Center
Recruiting
Creteil
Hopital Albert Michallon
Active, not recruiting
Grenoble Cedex 9
Centre Hospitalier Le Mans
Recruiting
Le Mans Cedex 9
Hopital Haut-Leveque
Recruiting
Pessac
Hopital Foch
Recruiting
Suresnes
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
Recruiting
Toulon
Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
Active, not recruiting
Toulouse Cedex 9
Gustave Roussy
Recruiting
Villejuif Cedex
Germany
Asklepios Fachkliniken Munchen-Gauting
Recruiting
Gauting
Thoraxklinik Heidelberg
Recruiting
Heidelberg
Klinikum Kempten-Oberallgau
Recruiting
Immenstadt
Greece
Sotiria General Hospital for Respiratory Diseases of Attica
Recruiting
Athens
University General Hospital of Athens Attikon
Recruiting
Athens
Iaso General Hospital
Recruiting
Cholargos
University General Hospital of Larissa
Recruiting
Larissa
General Oncology Hospital of Kifisia Oi Agioi Anargiroi
Recruiting
Nea Kifisia
Interbalkan Medical Center of Thessaloniki
Recruiting
Thessaloniki
Hong Kong Special Administrative Region
Humanity and Health Research Centre
Recruiting
Central
Pamela Youde Nethersole Eastern Hospital
Recruiting
Chai Wan
Queen Mary Hospital
Recruiting
Hong Kong
Queen Mary Hospital
Recruiting
Hong Kong
Hong Kong United Oncology Centre
Recruiting
Kowloon
Princess Margaret Hospital
Recruiting
Kowloon
Italy
Centro di Riferimento Oncologico di Aviano
Recruiting
Aviano
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Recruiting
Bologna
Azienda Ospedaliera Universitaria San Martino
Recruiting
Genova
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Recruiting
Meldola
Istituto Scientifico Universitario San Raffaele
Recruiting
Milano
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Recruiting
Napoli
Ospedale Santa Maria delle Croci
Recruiting
Ravenna
Mexico
Centro de Investigacion Medica Aguascalientes
Recruiting
Aguascalientes
Medica Sur
Recruiting
Ciudad De Mexico
Republic of Korea
Chungbuk National University Hospital
Recruiting
Cheongju-si
National Cancer Center
Recruiting
Goyang-si
Gachon University Gil Medical Center
Recruiting
Incheon
Korea University Anam Hospital
Recruiting
Seoul
Samsung Medical Center
Recruiting
Seoul
Seoul National University Hospital
Recruiting
Seoul
The Catholic University of Korea - Seoul St. Mary's Hospital
Recruiting
Seoul
Ajou University Hospital
Recruiting
Suwon
The Catholic University of Korea St. Vincent's Hospital
Recruiting
Suwon-si
Ulsan University Hospital
Recruiting
Ulsan
Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucaresti
Recruiting
Bucuresti
Institutul Oncologic Prof. Dr. Ion Chiricu
Recruiting
Cluj-napoca
Centrul de oncologie Euroclinic
Recruiting
Iasi
Oncocenter- Oncologie Clinica
Active, not recruiting
Timisoara
Russian Federation
State Institution of Healthcare Arkhangelsk Regional Clinical Oncology Dispensary
Recruiting
Arkhangelsk
Irkutsk Regional Oncology Center
Recruiting
Irkutsk
Moscow City Oncology Hospital Number 62
Recruiting
Moscow
N.N. Blokhin Russian Cancer Research Center
Recruiting
Moscow
State Budget Institution National Medical Research Center of Radiology of the Ministry of Heal
Recruiting
Moscow
VitaMed
Recruiting
Moscow
Omsk Regional Clinical Oncologic Dispensary
Recruiting
Omsk
Clinica Ultra Sound Diagnostic 4D
Recruiting
Pyatigorsk
Center of Palliative Medicine - Devita
Recruiting
Saint Petersburg
Leningrad Regional Clinical Hospital
Recruiting
Saint Petersburg
Saint Petersburg State Healthcare Institution Municipal Clinical Oncology Dispensary
Recruiting
Saint Petersburg
Euromedservice
Recruiting
Saint-petersburg
Saint Petersburg Clinical Scientific and Practical Center of Specialized Types of Medical Aid
Recruiting
Saint-petersburg
Spain
Hospital Teresa Herrera - Materno Infantil
Recruiting
A Coruna
Hospital Universitari Germans Trias i Pujol
Active, not recruiting
Badalona
Hospital Clinic i Provincial de Barcelona
Active, not recruiting
Barcelona
Hospital Universitari Vall d'Hebron
Recruiting
Barcelona
Hospital Clinico San Carlos
Active, not recruiting
Madrid
Hospital General Universitario Gregorio Maranon
Recruiting
Madrid
Hospital Universitario 12 de Octubre
Recruiting
Madrid
Hospital Universitario La Paz
Active, not recruiting
Madrid
Hospital Universitario Ramon Y Cajal
Active, not recruiting
Madrid
Hospital Regional Universitario de Malaga
Recruiting
Malaga
Hospital Universitari Sant Joan de Reus
Recruiting
Reus
Hospital Universitario Virgen Macarena
Active, not recruiting
Sevilla
Sweden
Karolinska Universitetssjukhuset - Solna
Recruiting
Solna
Uppsala Akademiska Sjukhus
Active, not recruiting
Uppsala
Taiwan
Changhua Christian Hospital
Recruiting
Changhua City
Hualien Tzu Chi Hospital
Active, not recruiting
Hualien City
Kaohsiung Medical University Hospital
Recruiting
Kaohsiung
National Cheng Kung University Hospital
Recruiting
Tainan
Chi Mei Hospital Liouying
Recruiting
Tainan City
National Taiwan University Hospital
Recruiting
Taipei
Chang Gung Memorial Hospital Linkou Branch
Not yet recruiting
Taoyuan City
Thailand
King Chulalongkorn Memorial Hospital
Active, not recruiting
Bangkok
Phramongkutklao Hospital
Active, not recruiting
Bangkok
Songklanagarind Hospital
Active, not recruiting
Songkhla
Contact Information
Primary
Takeda Study Registration Call Center
medinfoUS@takeda.com
+1-866-835-2233
Time Frame
Start Date: April 19, 2019
Estimated Completion Date: May 7, 2024
Participants
Target number of participants: 246
Treatments
Experimental: Brigatinib
Brigatinib 90 milligram (mg), tablets, orally, once daily 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.
Active Comparator: Alectinib
Alectinib 600 mg, capsules, orally twice daily until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.
Authors
Merrill Shum, Makenzi Evangelist, Alexander Spira, Michael Thomas, Petros Nikolinakos, Jane Chan, Felipe Palazzo, Kristina Lamberg-Lundstrom, Jasna Radic, Noemi Reguart Aransay, Niels Reinmuth, Olivier Molinier, Clarisse Audigier-Valette, Julien Mazieres, Denis Moro-Sibilot, Christos Chouaid, David Planchard, Remi Veillon, Christian Schumann, Norma Pilnik, James Chih-Hsin Yang, Ji Youn Han, Markus Rauter, Byoung-Yong Shim, Jesus Elvis Cabrera Luviano, Chung-Man, Chi Kin, Mei Wan Yeung, Denis Yurevich Yukalchuk, Yu-Chung, Elena Reutova, Daria Saenko, Jeronimo Rodriguez Cid, Anastassios Visvikis, Young-Joo Min, Yiping Zhang, Tso-Fu Wang, Ho Fun, Wojciech Morzycki, Yan-Qiu Zhao, Aurelia Alexandru, Diego Kaen, Jose Luis Gonzalez-Larriba, Clara Lucia Gozalvez, Enriqueta Felip Font, Chao-Jung Tsao, Teresa Moran, Dragan Trivanovic, Alessandra Bulotta, Zhe Liu, Sofia Baka, Mengzhao Wang, Shun Lu, Gongyan Chen, Constantin Volovat, Myung-Ju Ahn, Dong-Wan Kim, Jen-Yu Hung, Mikhail Dvorkin, Dingzhi Huang, Marina Nechaeva, Nina Mosina, Roxana Ioana Scheusan, Tudor-Eliade Ciuleanu, Ki Hyeong Lee, Carlo Genova, Sheng-Hao Lin, Fedor Moiseenko, Alessandro Morabito, Miroslav Samarzija, Alexander Luft, Andrea Ardizzoni, Xianghua Wu, Jianxing He, Vanesa Gregorc, Jian-Ying Zhou, Cheng-Ta Yang, Athanasios Kotsakis, Xiaoqing Liu, Konstantinos Syrigos, Eun Kyung Cho, Geoffrey Liu, Jin-Hyoung Kang, Wu-Chou Su, Patrapim Sunpaweravong, Pilar Garrido, Alessandra Bearz, Sergey Orlov, Elena Poddubskaya, Angelo Delmonte, Jun Zhao, Santiago Ponce Aix, David Vicente Baz, Mauricio Burotto, Vassilis Georgoulias, Yoon Ji Choi, Žarko Vrbica, Jian Fang, Antonio Calles Blanco, Hyun Woo Lee, Alexander Fedenko, Maria Rosario Garcia Campelo, Naiyarat Prasongsook, Daniil Stroyakovskiy, Rashida Orlova, Anne-Cecile Metivier, Signe Friesland, Ying Cheng, Manolo D'Arcangelo, Virote Sriuranpong, Manuel Cobo Dols, Anna Koumarianou, Javier de Castro Carpeno
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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