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Non-small Cell Lung CancerPhase 3ALTA-1LNCT02737501

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

A Phase 3 study testing Brigatinib and Crizotinib in people with Non-small Cell Lung Cancer and Lung Cancer, run by Ariad Pharmaceuticals at 91 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Brigatinib and Crizotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
91 sitesin 19 countries
Study dates
26 May 2016to 29 Jan 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have histologically or cytologically confirmed stage IIIB (and not a candidate for definitive 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 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.
  • Are a male or female participants greater than or equal to (>=)18 years old.
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  • 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 test documented prior to randomization.
  • For female and male participants who are fertile, agree to use a highly effective form of contraception, as defined by the study protocol.
  • 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.
  • Have the willingness and ability to comply with scheduled visit and study procedures.

Who cannot join

  • Previously received an investigational antineoplastic agent for NSCLC.
  • Previously received any prior tyrosine kinase inhibitor (TKI), including ALK-targeted TKIs.
  • Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
  • Received chemotherapy or radiation within 14 days of first dose of study drug, except stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT).
  • Received anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.
  • 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.
Show all 18Show fewer
  • 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.
  • 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.
  • Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
  • Be pregnant, planning a pregnancy, or breastfeeding.
  • Have significant, uncontrolled, or active cardiovascular disease, as defined by the study 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/or crizotinib 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, would compromise participant's safety or interfere with the evaluation of the study drug.

Trial locations and contacts

91 sites in 19 countries.

91 sites in 19 countries

Italy13 sites

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, 83100

  • Centro di Riferimento Oncologico di Aviano

    Aviano, Pordenone, 33081

  • Istituto Oncologico di Bari Giovanni Paolo II

    Bari, 70124

  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

    Bologna, 40138

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Forli-cesena, 47014

  • Istituto Scientifico Universitario San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera San Gerardo di Monza

    Monza, Monza E Brianza, 20052

  • Istituto Tumori Napoli Fondazione G. Pascale

    Naples, 80131

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    Novara, 28100

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia

    Perugia, 06132

  • Azienda Unita Sanitaria Locale di Ravenna

    Ravenna, 48121

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

Other trials in Italy

United States12 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Kaiser Permanente Bellflower Medical Offices

    Bellflower, California, 90706

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers - Boulder

    Boulder, Colorado, 80303-1385

  • Oncology Hematology Care - Blue Ash

    Cincinnati, Ohio, 45242-5665

  • Minnesota Oncology

    Coon Rapids, Minnesota, 55433

  • Sylvester Comprehensive Cancer Center

    Deerfield Beach, Florida, 33442

  • Virginia Cancer Specialists - Fairfax Office

    Fairfax, Virginia, 22031

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • USOR - Arizona Oncology Associates - Sedona

    Sedona, Arizona, 86336

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

Spain12 sites

  • Hospital Teresa Herrera - Materno Infantil

    A Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario Carlos Haya Malaga Instituto de Neurociencias Clinicas

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

South Korea8 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea

    Seoul, 06591

Other trials in South Korea

France7 sites

  • Centre de Lutte Contre le Cancer Francois Baclesse

    Caen, Basse-normandie, 14076

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, Île-de-France Region, 94010

  • Hopital Albert Michallon

    Grenoble, Auvergne-Rhône-Alpes, 38043

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008

  • Centre Hospitalier Universitaire Hopital Nord

    Marseille, Provence-Alpes-Côte d'Azur Region, 13915

  • Hopital Tenon

    Paris, Île-de-France Region, 75020

  • Hopital Charles Nicolle

    Rouen, Haute-normandie, 76041

Other trials in France

Germany6 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim

    Cologne, North Rhine-Westphalia, 51109

  • Universitatsklinik Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Studiengesellschaft Haemato-Onkologie Hamburg Prof. Laack und Partner

    Hamburg, 20251

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126

  • Pius Hospital Oldenburg

    Oldenburg, Lower Saxony, 26121

Other trials in Germany

United Kingdom6 sites

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • University College London

    London, England, NW1 2PG

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, England, SE1 9RT

  • Royal Marsden NHS Trust

    London, England, SW3 6JJ

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

Other trials in United Kingdom

Taiwan5 sites

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University

    Tainan, Taipei, 70403

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Australia4 sites

  • Monash Medical Centre

    Bentleigh East, Victoria, 3165

  • Saint Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Saint George Hospital

    Kogarah, New South Wales, 2217

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Netherlands4 sites

  • Antoni van Leeuwenhoekziekenhuis

    Amsterdam, North Holland, 1066 CX

  • Amphia Ziekenhuis - Locatie Langendijk Breda

    Breda, North Brabant, 4818 CK

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Isala Klinieken

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong

  • Queen Elizabeth Hospital

    Kowloon, 150001

  • Tuen Mun Hospital

    Tuenmen, New Territories

Other trials in Hong Kong

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre Singapore

    Singapore, 169610

  • OncoCare Cancer Centre

    Singapore, 258499

Other trials in Singapore

Austria2 sites

  • Universitatsklinium St. Polten

    Sankt Pölten, Lower Austria, 3100

  • Otto-Wagner-Spital Baumgartner Hohe

    Vienna, 1140

Other trials in Austria

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Denmark1 site

  • Odense University Hospital

    Odense C, 5000

Other trials in Denmark

Luxembourg1 site

  • Centre Hospitalier de Luxembourg - Hopital Municipal

    Luxembourg, 1210

Other trials in Luxembourg

Norway1 site

  • Radiumhospitalet

    Oslo, 0379

Other trials in Norway

Sweden1 site

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76

Other trials in Sweden

Switzerland1 site

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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).

Read the 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.

Being tested
Brigatinib, Crizotinib
Keywords
Non-small cell lung cancer, Non-small cell lung carcinoma, Epithelial lung cancer, Squamous cell carcinoma, Large cell carcinoma, Adenocarcinoma, Carcinoma, Anaplastic Lymphoma Kinase (ALK), Advanced Cancers, Brigatinib, AP26113
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Carcinoma, Squamous Cell, Carcinoma, Large Cell, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrigatinibDrug

    Brigatinib tablets

  • CrizotinibDrug

    Also called Xalkori

    Crizotinib tablets

Study groups in NCT02737501
Study groupRoleWhat they receive
Randomized Phase: Brigatinib 90 mg QD/180 QDExperimentalBrigatinib 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).
Receives: Drug: Brigatinib
Randomized Phase: Crizotinib 250 mg BIDActive comparatorCrizotinib 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).
Receives: Drug: Crizotinib
Crossover Phase: Brigatinib 90 mg QD/180 mg QDExperimentalParticipants 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).
Receives: Drug: Brigatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to end of study (Up to 56 months)

Secondary outcomes (9)

  1. 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.

    Measured: Baseline up to end of treatment (Up to 36 months)

  2. 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.

    Measured: Baseline up to end of treatment (Up to 36 months)

  3. 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.

    Measured: Baseline up to end of study (Up to 56 months)

  4. Overall Survival (OS)

    Overall survival is defined as the time from randomization until death due to any cause.

    Measured: Baseline up to end of study (Up to 56 months)

  5. 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.

    Measured: Baseline up to end of study (Up to 56 months)

  6. 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.

    Measured: Baseline up to end of treatment (Up to 36 months)

  7. 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.

    Measured: Baseline up to end of treatment (Up to 36 months)

  8. 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.

    Measured: From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)

  9. 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.

    Measured: Baseline and Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study start26 May 2016
  3. Primary completion28 Jul 2020
  4. Study completion29 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02737501
Sponsor's protocol ID
AP26113-13-301
Other IDs
U1111-1210-4363, 2015-003447-19, 2015
Acronym
ALTA-1L
Status last verified
Jul 2021
First submitted
30 Mar 2016
Last updated
20 Aug 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Al Tawil A, Lauseker M, Mansmann U. Estimating causal effects on quality of life under treatment discontinuation: the ALTA-1L trial. J Clin Epidemiol. 2026 May;193:112189. doi: 10.1016/j.jclinepi.2026.112189. Epub 2026 Feb 23.

    PubMed 41740899

  • Ahn MJ, Delmonte A, Ghosh S, Hochmair M, Yang TY, Yang JC, Han JY, Hansen KH, Wu Y, Wan Y, Lin HM, Kretz J, Hupf B, Kurec AM, Churchill EN, Fram RJ, Cabasag CJ, Goriya V, Zhao Y, Campelo MRG. Real-world treatment patterns and subsequent treatment effectiveness following frontline brigatinib in the ALTA-1L trial. Future Oncol. 2025 Dec;21(30):3935-3945. doi: 10.1080/14796694.2025.2592527. Epub 2025 Dec 18.

    PubMed 41410381

  • Al Tawil A, McGrath S, Ristl R, Mansmann U. Addressing treatment switching in the ALTA-1L trial with g-methods: exploring the impact of model specification. BMC Med Res Methodol. 2024 Dec 20;24(1):314. doi: 10.1186/s12874-024-02437-6.

    PubMed 39707229

  • 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.

    PubMed 32780660

  • 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.

    PubMed 30280657

  • 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.

    PubMed 28501139

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brigatinib and Crizotinib in people with Non-small Cell Lung Cancer and Lung Cancer, run by Ariad Pharmaceuticals at 91 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Italy, United States, Spain, South Korea, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to end of study (Up to 56 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02737501, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

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