AzTrials
AzTrials

ALK+ Advanced NSCLCPhase 3ALTA-3NCT03596866

A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

A Phase 3 study testing Brigatinib and Alectinib in people with ALK+ Advanced NSCLC, run by Takeda at 114 sites in 20 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

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ALK+ Advanced NSCLC
What is being tested?
Brigatinib and Alectinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
114 sitesin 20 countries
Study dates
19 Apr 2019to 18 Sep 2024
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 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 except for participants previously participating in the Brigatinib-2002 study (Note: crizotinib does not need to be the last therapy a participant received. The participant may have received chemotherapy as his/her last therapy).
Show all 20Show fewer
  • Treatment with crizotinib for at least 4 weeks before progression except for participants previously participating in the Brigatinib-2002 study.
  • Have had no other ALK inhibitor other than crizotinib except for participants previously participating in the Brigatinib-2002 study.
  • 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) version 4.03 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, at the time of initial screening, except for participants previously participating in the Brigatinib-2002 study 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).

Who cannot join

  • Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L) [NCT02737501].
  • Had received crizotinib within 7 days before randomization.
  • Have a history or presence at baseline of pulmonary interstitial disease, drug related pneumonitis, or radiation pneumonitis.
  • Have uncontrolled hypertension. Participants with hypertension should be under treatment for control of blood pressure upon study entry.
  • Had received systemic treatment with strong cytochrome P-450 (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14 days before randomization.
  • Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before randomization.
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  • Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated nonmetastatic 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.
  • Had received chemotherapy or radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.
  • Had received antineoplastic monoclonal antibodies within 30 days of randomization.
  • Had major surgery within 30 days of randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.
  • Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening (participants with asymptomatic brain metastases or participants who have stable symptoms and did not require an increased dose of corticosteroids to control symptoms within 7 days before randomization will be enrolled). Note: If a participant has worsening neurological symptoms or signs due to CNS metastasis, the participant needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants) for 7 days before randomization.
  • Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
  • Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to the following:
  • Myocardial infarction within 6 months before randomization.
  • Unstable angina within 6 months before randomization.
  • New York Heart Association Class III or IV heart failure within 6 months before randomization.
  • History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician.
  • Any history of clinically significant ventricular arrhythmia.
  • Had cerebrovascular accident or transient ischemic attack within 6 months before first dose of study drug.
  • Have malabsorption syndrome or other gastrointestinal illness or condition that could affect oral absorption of the study drug.
  • Have an ongoing or active infection, including but not limited to, the requirement for intravenous antibiotics.
  • Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history.
  • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. Testing is not required in the absence of history.
  • Any serious medical condition or psychiatric illness that could, in the investigator's opinion, potentially compromise participant safety or interfere with the completion of treatment according to this protocol.
  • Have a known or suspected hypersensitivity to brigatinib or alectinib or their excipients.
  • Life-threatening illness unrelated to cancer.
  • Female participants who are lactating and breastfeeding.
  • Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.

Trial locations and contacts

114 sites in 20 countries.

114 sites in 20 countries

China14 sites

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 100000

  • Peking Union Medical College Hospital - East

    Beijing, Beijing Municipality, 100032

  • Peking University Cancer Hospital/Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100036

  • The 307th Hospital of Chinese Peoples Liberation Army

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Jilin Provincial Cancer Hospital (Changchun Cancer Hospital)

    Changchun, Jilin, 13000

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 31000

  • Affiliated Tumor Hospital of Harbin Medical University - The 3rd Affiliated Hospital of HMU

    Harbin, Heilongjiang, 150081

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Chang Gung Memorial Hospital Linkou Branch

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Russia13 sites

  • State Institution of Healthcare Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arkhangelr, 163045

  • Irkutsk Regional Oncology Center

    Irkutsk, 664035

  • N.N. Blokhin Russian Cancer Research Center

    Moscow, 115478

  • VitaMed

    Moscow, 121309

  • State Budget Institution National Medical Research Center of Radiology of the Ministry of Heal

    Moscow, 125284

  • Moscow City Oncology Hospital Number 62

    Moscow, 143423

  • Omsk Regional Clinical Oncologic Dispensary

    Omsk, 644013

  • Clinica Ultra Sound Diagnostic 4D

    Pyatigorsk, Stavropol Kray, 357502

  • Euromedservice

    Saint Petersburg, Sankt-Peterburg, 196603

  • Saint Petersburg Clinical Scientific and Practical Center of Specialized Types of Medical Aid

    Saint Petersburg, Sankt-Peterburg, 197758

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Center of Palliative Medicine - Devita

    Saint Petersburg, 197343

  • Saint Petersburg State Healthcare Institution Municipal Clinical Oncology Dispensary

    Saint Petersburg, 197758

Other trials in Russia

Spain12 sites

  • Hospital Teresa Herrera - Materno Infantil

    A Coruña, LA Coruna, 15006

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

South Korea10 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, Gyeonggi-do, 21565

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea - Seoul St. Mary's Hospital

    Seoul, 06591

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

  • Ulsan University Hospital

    Ulsan, Gyeongsangnam-do, 44033

Other trials in South Korea

France9 sites

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, Île-de-France Region, 94010

  • Fudan University Shanghai Cancer Center

    Créteil, Île-de-France Region, 94010

  • Hopital Albert Michallon

    Grenoble, Auvergne-Rhône-Alpes, 38043

  • Centre Hospitalier Le Mans

    Le Mans, Pays de la Loire Region, 72037

  • Hopital Haut-Leveque

    Pessac, Aquitaine, 33604

  • Hopital Foch

    Suresnes, Île-de-France Region, 92151

  • Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

    Toulon, Provence-Alpes-Côte d'Azur Region, 83056

  • Centre Hospitalier Universitaire de Toulouse- Hopital Larrey

    Toulouse, Midi-pyrenees, 31059

  • Gustave Roussy

    Villejuif, Île-de-France Region, 94805

Other trials in France

Italy7 sites

  • Centro di Riferimento Oncologico di Aviano

    Aviano, Pordenone, 33081

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

    Bologna, 40138

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

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

    Meldola, Forli-cesena, 47014

  • Istituto Scientifico Universitario San Raffaele

    Milan, 20132

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121

Other trials in Italy

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Hualien Tzu Chi Hospital

    Hualien City, 970

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Chi Mei Hospital Liouying

    Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

Greece6 sites

  • University General Hospital of Athens Attikon

    Athens, Attica, 12462

  • Sotiria General Hospital for Respiratory Diseases of Attica

    Athens, 11527

  • Iaso General Hospital

    Cholargós, Attica, 15562

  • University General Hospital of Larissa

    Larissa, Thessaly, 41110

  • General Oncology Hospital of Kifisia Oi Agioi Anargiroi

    Nea Kifissia, Attica, 14564

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, Macedonia, 57001

Other trials in Greece

Hong Kong6 sites

  • Humanity and Health Research Centre

    Central

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan, Eastern District, 999077

  • Queen Mary Hospital

    Hong Kong, 00852

  • Queen Mary Hospital

    Hong Kong

  • Hong Kong United Oncology Centre

    Kowloon

  • Princess Margaret Hospital

    Kowloon

Other trials in Hong Kong

Croatia5 sites

  • Fudan University Shanghai Cancer Center

    Dubrovnik, Dubrovnik-Neretva County, 20 000

  • Opca bolnica Dubrovnik

    Dubrovnik, Dubrovnik-Neretva County, 20 000

  • General Hospital Pula

    Pula, 52100

  • Klinicki bolnicki centar Sestre milosrdnice

    Zagreb, 10000

  • Klinika za Pulmologiju

    Zagreb, 10000

Other trials in Croatia

United States4 sites

  • New York Oncology Hematology - Albany Medical Center

    Albany, New York, 12208

  • University Cancer and Blood Center

    Athens, Georgia, 30607

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90602

Other trials in United States

Romania4 sites

  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucaresti

    Bucharest, 022328

  • Institutul Oncologic Prof. Dr. Ion Chiricu

    Cluj-Napoca, Cluj, 400015

  • Centrul de oncologie Euroclinic

    Iași, 700106

  • Oncocenter- Oncologie Clinica

    Timișoara, Timiș County, 300166

Other trials in Romania

Argentina3 sites

  • Sanatorio Duarte Quiros

    Córdoba, 5000

  • Centro Oncologico Riojano Integral

    La Rioja, F5300COE

  • Centro Para la Atencion Integral del Paciente Oncologico

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Germany3 sites

  • Asklepios Fachkliniken Munchen-Gauting

    Gauting, Bavaria, 82131

  • Thoraxklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126

  • Klinikum Kempten-Oberallgau

    Immenstadt im Allgäu, Bavaria, 87509

Other trials in Germany

Thailand3 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, Bangkok Metropolis, 10330

  • Phramongkutklao Hospital

    Bangkok, Bangkok Metropolis, 10400

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Canada2 sites

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Toronto University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Mexico2 sites

  • Centro de Investigacion Medica Aguascalientes

    Aguascalientes, 20116

  • Medica Sur

    Mexico City, Mexico City, 14050

Other trials in Mexico

Sweden2 sites

  • Karolinska Universitetssjukhuset - Solna

    Solna, Stockholm County, 171 64

  • Uppsala Akademiska Sjukhus

    Uppsala, 751 85

Other trials in Sweden

Austria1 site

  • Klinikum Klagenfurt Am Worthersee

    Klagenfurt, Carinthia, 9020

Other trials in Austria

Chile1 site

  • Centro de Investigacion Clinica Bradford Hill

    Recoleta, Santiago Metropolitan, 76894

Other trials in Chile

About this study

Official title: 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®)

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:

Read more
  • 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.

Read the detailed description

The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to benefit people with anaplastic lymphoma kinase-positive (ALK+) NSCLC.

The comparator drug is called alectinib. Alectinib has been demonstrated to benefit people with ALK+ NSCLC. Both drugs belong to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. Both drugs are taken by mouth. Both drugs are approved by the United States Food and Drug Administration (US FDA).

The study will enroll approximately 246 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups:

  • Brigatinib
  • Alectinib

All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study. For each participant eligible to continue in the study and to facilitate the remaining participants from Brigatinib-2002 (NCT03535740) to have continued treatment access, the study extension phase may be initiated for participants to continue receiving their randomized study treatment (i.e., brigatinib or alectinib) until they meet at least one of the treatment discontinuation criteria.

This multi-center trial will be conducted in the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, and Thailand. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

Being tested
Brigatinib, Alectinib
Keywords
Drug Therapy

What participants receive

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

  • BrigatinibDrug

    Also called Alunbrig

    Brigatinib Tablets.

  • AlectinibDrug

    Also called Alecensa

    Alectinib Capsules.

Study groups in NCT03596866
Study groupRoleWhat they receive
BrigatinibExperimentalParticipants were administered brigatinib 90 milligrams (mg), tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.
Receives: Drug: Brigatinib
AlectinibActive comparatorParticipants were administered alectinib 600 mg, capsules, orally, twice daily (BID) until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Receives: Drug: Alectinib

What is being measured

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

  1. Progression-free Survival (PFS) as Assessed by Blinded Independent Review Committee (BIRC) Per RECIST v1.1

    PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by BIRC, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.

    Measured: Up to 33.8 months

Secondary outcomes (10)

  1. Overall Survival (OS)

    OS is defined as the time interval from the date of randomization until death due to any cause in the full analysis set. OS was censored on the date of last contact for those participants who are alive.

    Measured: Up to 64 months

  2. PFS as Assessed by Investigator Per RECIST v1.1

    PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by investigator, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.

    Measured: Up to 33.8 months

  3. Objective Response Rate (ORR) as Assessed by BIRC and Investigator Per RECIST v1.1

    ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), using RECIST v1.1 after the initiation of study treatment. Percentages were rounded off to the nearest single decimal place.

    Measured: Up to 33.8 months

  4. Duration of Response (DOR) as Assessed by BIRC and Investigator Per RECIST v1.1

    DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the progressive disease (PD) is objectively documented or death, as assessed by the investigator and BIRC, using RECIST v1.1. Participants who did not progress or died, were censored at the last tumor assessment date prior to receiving subsequent anticancer therapy.

    Measured: Up to 33.8 months

  5. Time to Response as Assessed by Investigator and BIRC Per RECIST v1.1

    Time to response is defined as the time interval from randomization until the initial observation of CR or PR, as assessed by the investigator and BIRC, using RECIST v1.1. Time to response will be summarized using descriptive statistics in participants with confirmed objective response.

    Measured: Up to 33.8 months

  6. Confirmed Intracranial Objective Response Rate (iORR) as Assessed by BIRC Per Modified RECIST v1.1

    Confirmed iORR, as assessed by the BIRC, is defined as the percentage of the participants who have achieved CR or PR in the central nervous system (CNS) per a modification RECIST v1.1 after the initiation of study treatment in participants with CNS metastases at baseline. Percentages were rounded off to the nearest single decimal place.

    Measured: Up to 33.8 months

  7. Intracranial Duration of Response (iDOR) as Assessed by the BIRC Per Modified RECIST v1.1

    iDOR, as assessed by the BIRC per modified RECIST v1.1, is defined as the time interval from the time that the measurement criteria are first met for CR or PR in the CNS (whichever is first recorded) until the first date that the PD in the CNS is objectively documented or death. Participants who did not progress or died, were censored at the last iCNS tumor assessment date prior to receiving subsequent anticancer therapy.

    Measured: Up to 33.8 months

  8. Cumulative Incidence of Intracranial Disease Progression (iPD) as Assessed by BIRC Per Modified RECIST v1.1

    Time to iPD as assessed by the BIRC,is defined as time interval from date of randomization until first date at which iPD is objectively documented via a modification of RECIST v1.1 without prior systemic progression (PD) or death. Time to iPD was analyzed within a competing risk framework (with systemic progression and death as the competing risks) by estimating the cumulative incidence function (CIF) within each arm. The CIF is a function of time, and indicates the probability of an event (e.g. iPD without prior PD or death) occurring by the specified time. The estimated CIFs were analyzed using Grey's Test and the estimated probability of CIFs is reported at pre-specified landmark times (6, 12, 18 and 24 months).

    Measured: 6, 12, 18 and 24 months

  9. Health-Related Quality of Life (HRQOL) From European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score

    EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL.

    Measured: Up to 33.8 months

  10. HRQOL From EORTC QLQ- Lung Cancer (LC) 13

    HRQOL scores were assessed with European Organization for Research and Treatment (EORTC), its lung cancer module QLQ-LC13. QLQ-LC13 contains 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Subscales were scored on a range of 0 to 100. Higher symptom score = greater degree of symptom severity.

    Measured: Up to 33.8 months

Timeline

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

  1. First posted24 Jul 2018
  2. Study start19 Apr 2019
  3. Primary completion27 Feb 2024
  4. Study completion18 Sep 2024

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
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03596866
Sponsor's protocol ID
Brigatinib-3001
Other IDs
2018-001957-29, 2018
Acronym
ALTA-3
Status last verified
Sep 2025
First submitted
13 Jul 2018
Last updated
12 Sep 2025
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

  • Yang JC, Liu G, Lu S, He J, Burotto M, Ahn MJ, Kim DW, Liu X, Zhao Y, Vincent S, Yin J, Ma X, Lin HM, Popat S. Brigatinib Versus Alectinib in ALK-Positive NSCLC After Disease Progression on Crizotinib: Results of Phase 3 ALTA-3 Trial. J Thorac Oncol. 2023 Dec;18(12):1743-1755. doi: 10.1016/j.jtho.2023.08.010. Epub 2023 Aug 12.

    PubMed 37574132

  • Popat S, Liu G, Lu S, Song G, Ma X, Yang JC. Brigatinib vs alectinib in crizotinib-resistant advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALTA-3). Future Oncol. 2021 Nov;17(32):4237-4247. doi: 10.2217/fon-2021-0608. Epub 2021 Aug 23.

    PubMed 34423676

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brigatinib and Alectinib in people with ALK+ Advanced NSCLC, run by Takeda at 114 sites in 20 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 20 inclusion and 28 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in China, Russia, Spain, South Korea, France and 15 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 19 Feb 2025). 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) as Assessed by Blinded Independent Review Committee (BIRC) Per RECIST v1.1 (time frame: Up to 33.8 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 NCT03596866, which also lists 2 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 12 Sep 2025.

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