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Lung cancer showdown: which targeted pill works better after crizotinib fails?

NCT ID NCT03596866

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 3 trial tested two targeted drugs, brigatinib and alectinib, in 248 people with advanced ALK-positive non-small-cell lung cancer whose cancer had worsened after taking crizotinib. Participants were randomly assigned to take either brigatinib or alectinib daily. The main goal was to see which drug better stopped the cancer from growing. The study is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Brigatinib (Alunbrig) and alectinib (Alecensa)
What this could lead to
If brigatinib works better than alectinib, it could become a new standard treatment for people with ALK-positive lung cancer whose cancer has stopped responding to crizotinib.
What could go wrong
This trial is completed, but results may not apply to all patients. Both drugs can cause side effects like nausea, fatigue, or lung inflammation. The study is open-label, so both patients and doctors know which drug is given, which can introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

248 people

The number who actually took part.

Started

Apr 2019

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 2. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC. 3. 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). 4. 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). 5. Treatment with crizotinib for at least 4 weeks before progression except for participants previously participating in the Brigatinib-2002 study. 6. Have had no other ALK inhibitor other than crizotinib except for participants previously participating in the Brigatinib-2002 study. 7. 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). 8. Have at least 1 measurable (that is, target) lesion per RECIST v1.1. 9. 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). 10. 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. 11. Suitable venous access for study-required blood sampling (that is, including pharmacokinetic \[PK\] and laboratory safety tests). Exclusion Criteria: 1. Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L) \[NCT02737501\]. 2. Had received crizotinib within 7 days before randomization. 3. Have a history or presence at baseline of pulmonary interstitial disease, drug related pneumonitis, or radiation pneumonitis. 4. Have uncontrolled hypertension. Participants with hypertension should be under treatment for control of blood pressure upon study entry. 5. 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. 6. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before randomization. 7. 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. 8. Had received chemotherapy or radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy. 9. Had received antineoplastic monoclonal antibodies within 30 days of randomization. 10. Had major surgery within 30 days of randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed. 11. 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. 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed. 13. 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. 14. Had cerebrovascular accident or transient ischemic attack within 6 months before first dose of study drug. 15. Have malabsorption syndrome or other gastrointestinal illness or condition that could affect oral absorption of the study drug. 16. Have an ongoing or active infection, including but not limited to, the requirement for intravenous antibiotics. 17. Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history. 18. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. Testing is not required in the absence of history. 19. 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. 20. Have a known or suspected hypersensitivity to brigatinib or alectinib or their excipients. 21. Life-threatening illness unrelated to cancer. 22. Female participants who are lactating and breastfeeding. 23. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALK+ advanced NSCLC

Contacts and locations

Locations

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

    Harbin, Heilongjiang, 150081, China

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Asklepios Fachkliniken Munchen-Gauting

    Gauting, Bavaria, 82131, Germany

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132, Italy

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

    Bologna, 40138, Italy

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 100000, China

  • Center of Palliative Medicine - Devita

    Saint Petersburg, 197343, Russia

  • Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

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

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, Île-de-France Region, 94010, France

  • Centre Hospitalier Le Mans

    Le Mans, Pays de la Loire Region, 72037, France

  • Centre Hospitalier Universitaire de Toulouse- Hopital Larrey

    Toulouse, Midi-pyrenees, 31059, France

  • Centro Oncologico Riojano Integral

    La Rioja, F5300COE, Argentina

  • Centro Para la Atencion Integral del Paciente Oncologico

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Centro de Investigacion Clinica Bradford Hill

    Recoleta, Santiago Metropolitan, 76894, Chile

  • Centro de Investigacion Medica Aguascalientes

    Aguascalientes, 20116, Mexico

  • Centro di Riferimento Oncologico di Aviano

    Aviano, Pordenone, 33081, Italy

  • Centrul de oncologie Euroclinic

    Iași, 700106, Romania

  • Chang Gung Memorial Hospital Linkou Branch

    Tianjin, Tianjin Municipality, 300060, China

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan City, 333, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Chi Mei Hospital Liouying

    Tainan, 73657, Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Clinica Ultra Sound Diagnostic 4D

    Pyatigorsk, Stavropol Kray, 357502, Russia

  • Euromedservice

    Saint Petersburg, Sankt-Peterburg, 196603, Russia

  • Fudan University Shanghai Cancer Center

    Dubrovnik, Dubrovnik-Neretva County, 20 000, Croatia

  • Fudan University Shanghai Cancer Center

    Créteil, Île-de-France Region, 94010, France

  • Gachon University Gil Medical Center

    Incheon, Gyeonggi-do, 21565, South Korea

  • General Hospital Pula

    Pula, 52100, Croatia

  • General Oncology Hospital of Kifisia Oi Agioi Anargiroi

    Nea Kifissia, Attica, 14564, Greece

  • Gustave Roussy

    Villejuif, Île-de-France Region, 94805, France

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hong Kong United Oncology Centre

    Kowloon, Hong Kong

  • Hopital Albert Michallon

    Grenoble, Auvergne-Rhône-Alpes, 38043, France

  • Hopital Foch

    Suresnes, Île-de-France Region, 92151, France

  • Hopital Haut-Leveque

    Pessac, Aquitaine, 33604, France

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Teresa Herrera - Materno Infantil

    A Coruña, LA Coruna, 15006, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hualien Tzu Chi Hospital

    Hualien City, 970, Taiwan

  • Humanity and Health Research Centre

    Central, Hong Kong

  • Iaso General Hospital

    Cholargós, Attica, 15562, Greece

  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucaresti

    Bucharest, 022328, Romania

  • Institutul Oncologic Prof. Dr. Ion Chiricu

    Cluj-Napoca, Cluj, 400015, Romania

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, Macedonia, 57001, Greece

  • Irkutsk Regional Oncology Center

    Irkutsk, 664035, Russia

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131, Italy

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

    Meldola, Forli-cesena, 47014, Italy

  • Istituto Scientifico Universitario San Raffaele

    Milan, 20132, Italy

  • Jilin Provincial Cancer Hospital (Changchun Cancer Hospital)

    Changchun, Jilin, 13000, China

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807, Taiwan

  • Karolinska Universitetssjukhuset - Solna

    Solna, Stockholm County, 171 64, Sweden

  • King Chulalongkorn Memorial Hospital

    Bangkok, Bangkok Metropolis, 10330, Thailand

  • Klinicki bolnicki centar Sestre milosrdnice

    Zagreb, 10000, Croatia

  • Klinika za Pulmologiju

    Zagreb, 10000, Croatia

  • Klinikum Kempten-Oberallgau

    Immenstadt im Allgäu, Bavaria, 87509, Germany

  • Klinikum Klagenfurt Am Worthersee

    Klagenfurt, Carinthia, 9020, Austria

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291, Russia

  • Medica Sur

    Mexico City, Mexico City, 14050, Mexico

  • Moscow City Oncology Hospital Number 62

    Moscow, 143423, Russia

  • N.N. Blokhin Russian Cancer Research Center

    Moscow, 115478, Russia

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • New York Oncology Hematology - Albany Medical Center

    Albany, New York, 12208, United States

  • Omsk Regional Clinical Oncologic Dispensary

    Omsk, 644013, Russia

  • Oncocenter- Oncologie Clinica

    Timișoara, Timiș County, 300166, Romania

  • Opca bolnica Dubrovnik

    Dubrovnik, Dubrovnik-Neretva County, 20 000, Croatia

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121, Italy

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan, Eastern District, 999077, Hong Kong

  • Peking Union Medical College Hospital - East

    Beijing, Beijing Municipality, 100032, China

  • Peking University Cancer Hospital/Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100036, China

  • Phramongkutklao Hospital

    Bangkok, Bangkok Metropolis, 10400, Thailand

  • Princess Margaret Hospital

    Kowloon, Hong Kong

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Queen Mary Hospital

    Hong Kong, 00852, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

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

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Saint Petersburg State Healthcare Institution Municipal Clinical Oncology Dispensary

    Saint Petersburg, 197758, Russia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sanatorio Duarte Quiros

    Córdoba, 5000, Argentina

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030, China

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Sotiria General Hospital for Respiratory Diseases of Attica

    Athens, 11527, Greece

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

    Moscow, 125284, Russia

  • State Institution of Healthcare Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arkhangelr, 163045, Russia

  • The 307th Hospital of Chinese Peoples Liberation Army

    Beijing, Beijing Municipality, 100071, China

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

    Seoul, 06591, South Korea

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

    Suwon, Gyeonggi-do, 16247, South Korea

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 31000, China

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90602, United States

  • Thoraxklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Toronto University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • Ulsan University Hospital

    Ulsan, Gyeongsangnam-do, 44033, South Korea

  • University Cancer and Blood Center

    Athens, Georgia, 30607, United States

  • University General Hospital of Athens Attikon

    Athens, Attica, 12462, Greece

  • University General Hospital of Larissa

    Larissa, Thessaly, 41110, Greece

  • Uppsala Akademiska Sjukhus

    Uppsala, 751 85, Sweden

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • VitaMed

    Moscow, 121309, Russia

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310003, China