ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants (ALTA-1L)

A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer

The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).

Study Overview

• Status: Completed
• Conditions: Carcinoma; Lung Cancer; Non-small Cell Lung Cancer; Advanced Malignancies
• Intervention / Treatment: Drug: Brigatinib; Drug: Crizotinib

Detailed Description

The purpose of this phase III, randomized, open-label, comparative, multicenter, international study is to compare the efficacy and safety of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic NSCLC participants who have not previously been treated with an ALK inhibitor. Participants will be stratified by the presence of CNS metastases at baseline and prior chemotherapy used for locally advanced or metastatic disease. Participants will be randomized in a 1:1 ratio to receive either brigatinib, 90 mg orally once daily (QD) for 7 days, then a 180 mg orally QD, or crizotinib, 250 mg orally twice daily (BID). Participants will receive treatment until disease progression, intolerable toxicity, consent withdrawal, or death. Crossover from crizotinib to brigatinib is also permitted.

The total estimated duration of the study is at least 4.5 years, including 1.5 years to accrue participants, with at least 3 years for treatment and follow-up.

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Saint George Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Victoria
    • Bentleigh East, Victoria, Australia, 3165
      • Monash Medical Centre
    • Fitzroy, Victoria, Australia, 3065
      • Saint Vincent's Hospital Melbourne
• Austria
  • Vienna, Austria, 1140
    • Otto-Wagner-Spital Baumgartner Hohe
  • Lower Austria
    • Sankt Polten, Lower Austria, Austria, 3100
      • Universitatsklinium St. Polten
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• Denmark
  • Odense C, Denmark, 5000
    • Odense University Hospital
• France
  • Basse-normandie
    • CAEN Cedex 5, Basse-normandie, France, 14076
      • Centre de Lutte Contre le Cancer François Baclesse
  • Haute-normandie
    • Rouen, Haute-normandie, France, 76041
      • Hopital Charles Nicolle
  • Ile-de-france
    • Creteil, Ile-de-france, France, 94010
      • Centre Hospitalier Intercommunal de Créteil
    • Paris, Ile-de-france, France, 75020
      • Hôpital Tenon
  • Provence Alpes COTE D'azur
    • Marseille Cedex 20, Provence Alpes COTE D'azur, France, 13915
      • Centre Hospitalier Universitaire Hôpital Nord
  • Rhone-alpes
    • Grenoble Cedex 9, Rhone-alpes, France, 38043
      • Hôpital Albert Michallon
    • Lyon, Rhone-alpes, France, 69008
      • Centre Léon Bérard
• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Hamburg, Germany, 20251
    • Studiengesellschaft Haemato-Onkologie Hamburg Prof. Laack und Partner
  • Baden-wuerttemberg
    • Freiburg, Baden-wuerttemberg, Germany, 79106
      • Universitätsklinik Freiburg
    • Heidelberg, Baden-wuerttemberg, Germany, 69126
      • Thoraxklinik Heidelberg gGmbH
  • Niedersachsen
    • Oldenburg, Niedersachsen, Germany, 26121
      • Pius Hospital Oldenburg
  • Nordrhein-westfalen
    • Koln, Nordrhein-westfalen, Germany, 51109
      • Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Kowloon, Hong Kong, 150001
    • Queen Elizabeth Hospital
  • New Territories
    • Tuen Mun, New Territories, Hong Kong
      • Tuen Mun Hospital
• Italy
  • Avellino, Italy, 83100
    • Azienda Ospedaliera San Giuseppe Moscati
  • Bari, Italy, 70124
    • Istituto Oncologico di Bari Giovanni Paolo II
  • Bologna, Italy, 40138
    • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia
  • Milano, Italy, 20132
    • Istituto scientifico universitario San Raffaele
  • Napoli, Italy, 80131
    • Istituto Tumori Napoli Fondazione G. Pascale
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore della Carita
  • Perugia, Italy, 06132
    • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
  • Ravenna, Italy, 48121
    • Azienda Unita Sanitaria Locale di Ravenna
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Bio-Medico
  • Forli-cesena
    • Meldola, Forli-cesena, Italy, 47014
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20052
      • Azienda Ospedaliera San Gerardo di Monza
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro di Riferimento Oncologico di Aviano
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea
  • Chungcheongbuk-do
    • Cheongju, Chungcheongbuk-do, Korea, Republic of, 28644
      • Chungbuk National University Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Centre Hospitalier de Luxembourg - Hopital Municipal
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Noord-brabant
    • Breda, Noord-brabant, Netherlands, 4818 CK
      • Amphia Ziekenhuis - Locatie Langendijk Breda
  • Noord-holland
    • Amsterdam, Noord-holland, Netherlands, 1066 CX
      • Antoni Van Leeuwenhoekziekenhuis
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 AB
      • Isala Klinieken
• Norway
  • Oslo, Norway, 0379
    • Radiumhospitalet
• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore
  • Singapore, Singapore, 119228
    • National University Hospital
  • Singapore, Singapore, 258499
    • Oncocare Cancer Centre
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • La Coruna, Spain, 15006
    • Hospital Teresa Herrera - Materno Infantil
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya Malaga Instituto de Neurociencias Clinicas
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias I Pujol
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset
• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich
• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei
    • Tainan, Taipei, Taiwan, 70403
      • National Cheng Kung University
• United Kingdom
  • England
    • Leicester, England, United Kingdom, LE1 5WW
      • Leicester Royal Infirmary
    • London, England, United Kingdom, SW3 6JJ
      • Royal Marsden NHS Trust
    • London, England, United Kingdom, SE1 9Rt
      • Guy's and Saint Thomas' NHS Foundation Trust
    • London, England, United Kingdom, NW1 2PG
      • University College London
    • Maidstone, England, United Kingdom, ME16 9QQ
      • Maidstone Hospital
    • Manchester, England, United Kingdom, M20 4BX
      • The Christie NHS Foundation Trust
• United States
  • Arizona
    • Sedona, Arizona, United States, 86336
      • USOR - Arizona Oncology Associates - Sedona
  • California
    • Bellflower, California, United States, 90706
      • Kaiser Permanente Bellflower Medical Offices
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
    • Boulder, Colorado, United States, 80303-1385
      • Rocky Mountain Cancer Centers - Boulder
  • Florida
    • Deerfield Beach, Florida, United States, 33442
      • Sylvester Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Oncology
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242-5665
      • Oncology Hematology Care - Blue Ash
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists - Fairfax Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Have histologically or cytologically confirmed stage IIIB (and not a candidate for definitive multimodality therapy) or stage four (IV) NSCLC.
2. Must have documented ALK rearrangement.
3. Have sufficient tumor tissue available for central analysis.
4. Have at least 1 measurable (that is, target) lesion per RECIST v1.1.
5. Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (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.
6. Are a male or female participants greater than or equal to (>=)18 years old.
7. Have adequate organ function, as defined by the study protocol.
8. Have Eastern Cooperative Oncology Group (ECOG) performance status <=2.
9. 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.
10. For female participants of childbearing potential, have a negative pregnancy test documented prior to randomization.
11. For female and male participants who are fertile, agree to use a highly effective form of contraception, as defined by the study protocol.
12. Provide signed and dated informed consent indicating that the participants has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
13. Have the willingness and ability to comply with scheduled visit and study procedures.

Exclusion Criteria:

1. Previously received an investigational antineoplastic agent for NSCLC.
2. Previously received any prior tyrosine kinase inhibitor (TKI), including ALK-targeted TKIs.
3. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
4. Received chemotherapy or radiation within 14 days of first dose of study drug, except stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT).
5. Received anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.
6. Had major surgery within 30 days of the first dose of study drug, minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.
7. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
8. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization.
9. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
10. Be pregnant, planning a pregnancy, or breastfeeding.
11. Have significant, uncontrolled, or active cardiovascular disease, as defined by the study protocol.
12. Have uncontrolled hypertension.
13. Have a history or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
14. Have an ongoing or active infection.
15. Have a known history of human immunodeficiency virus (HIV) infection.
16. Have a known or suspected hypersensitivity to brigatinib or its excipients and/or crizotinib or its excipients.
17. Have malabsorption syndrome or other gastrointestinal (GI) illness or condition.
18. Have any condition or illness that, in the opinion of the investigator, would compromise participant's safety or interfere with the evaluation of the study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized Phase: Brigatinib 90 mg QD/180 QD; Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).	Drug: Brigatinib; Brigatinib tablets
Active Comparator: Randomized Phase: Crizotinib 250 mg BID; Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).	Drug: Crizotinib; Crizotinib tablets; Other Names: Xalkori
Experimental: Crossover Phase: Brigatinib 90 mg QD/180 mg QD; Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).	Drug: Brigatinib; Brigatinib tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS as assessed by Blinded Independent Review Committee (BIRC), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, was defined as the time interval from the date of randomization until the date of the first documented PD event. The data was censored for participants without a PFS event.	Up to end of study (Up to 56 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Objective Response Rate (ORR)	ORR was defined as percentage of participants who achieved Complete response (CR) or Partial responses (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1 criteria. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to less than (<) 10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.	Baseline up to end of treatment (Up to 36 months)
Confirmed Intracranial ORR (iORR)	ORR was defined as percentage of participants who achieved CR or PR in the central nervous system (CNS) in randomized participants with intracranial CNS metastasis at baseline. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.	Baseline up to end of treatment (Up to 36 months)
Intracranial Progression Free Survival	Intracranial PFS as assessed by BIRC, is defined as the time from randomization until first CNS PD is documented, or death due to any cause. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions.	Baseline up to end of study (Up to 56 months)
Overall Survival (OS)	Overall survival is defined as the time from randomization until death due to any cause.	Baseline up to end of study (Up to 56 months)
Duration of Response (DOR)	Duration of response as assessed by BIRC, is defined as the time interval from the date that the criteria are first met for CR/PR (whichever is first recorded) until the first date that progressive disease (PD) is objectively documented. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30 % decrease in the SLD of target lesions, taking as reference the baseline sum diameters. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and for non-target lesions, unequivocal progression of existing non-target lesions.	Baseline up to end of study (Up to 56 months)
Time to Response (TTR)	Time to response as assessed by BIRC, assessment and is defined as the time interval from the date of randomization until the initial observation of CR or PR. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.	Baseline up to end of treatment (Up to 36 months)
Disease Control Rate (DCR)	Disease control as assessed by BIRC, defined as percentage of randomized participants who have achieved CR, PR, or stable disease (SD) after randomization. CR defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (<10 mm short axis), normalization of tumor marker level for non-target lesions. PR: at least a 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: SLD increased by at least 20% from the smallest value on study, SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions.	Baseline up to end of treatment (Up to 36 months)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a participant. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug (i.e., occurs after the first dose of study drug) is also an AE. TEAEs are defined as AEs starting/worsening on or after the first dose of study treatment and no later than the earliest of 30 days after the last dose of the treatment to which the participant was assigned, or the day before start of brigatinib therapy in crossover participant.	From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)
Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0)	HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement.	Baseline and Month 36

Collaborators and Investigators

• Sponsor: Ariad Pharmaceuticals

Publications and helpful links

General Publications

• Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available.
• Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, Garcia Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. J Clin Oncol. 2020 Nov 1;38(31):3592-3603. doi: 10.1200/JCO.20.00505. Epub 2020 Aug 11.
• Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY, Lee JS, Hochmair MJ, Li JY, Chang GC, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim DW, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2027-2039. doi: 10.1056/NEJMoa1810171. Epub 2018 Sep 25.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2016
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): January 29, 2021

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Carcinoma; Adenocarcinoma; Non-small cell lung cancer; Advanced Cancers; Squamous cell carcinoma; Anaplastic Lymphoma Kinase (ALK); Non-small cell lung carcinoma; Large cell carcinoma; Epithelial lung cancer; Brigatinib; AP26113
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Crizotinib
• Other Study ID Numbers: AP26113-13-301; U1111-1210-4363 (Other Identifier: WHO); 2015-003447-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No