A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months.

Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Alectnib; Drug: Cisplatin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • St Leonards, New South Wales, Australia, 2065
      • GenesisCare North Shore
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Center
• Austria
  • Vienna, Austria, 1210
    • Krankenhaus Nord - Klinik Floridsdorf
• Belarus
  • Grodnenskaya
    • Hrodna, Grodnenskaya, Belarus, 230030
      • Healthcare Institution Grodno University Hospital
  • Homyel'skaya Voblasts'
    • Homyel, Homyel'skaya Voblasts', Belarus, 246012
      • Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?
  • Vitebsk Oblast
    • Vitebsk, Vitebsk Oblast, Belarus, BU-210603
      • Vitebsk Regional Clinical Oncology Dispensary
• Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinical Center University of Sarajevo
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun, China, 132013
    • Jilin Cancer Hospital
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Fujian, China, 350001
    • Fujian Medical University Union Hospital
  • Guangzhou, China, 510080
    • Guangdong General Hospital
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Jinan, China, 250117
    • Shandong Cancer Hospital
  • Shanghai, China, 200030
    • Shanghai Chest Hospital
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shenzhen, China, 510852
    • Shenzhen People's Hospital
  • Wuhan, China, 430023
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
• Denmark
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Onkologisk Afdeling R
• Egypt
  • Cairo, Egypt, 11555
    • Kasr Eieny Uni Hospital
• France
  • Angers, France, 49933
    • Chu Angers
  • Marseille, France, 13015
    • Hopital Nord AP-HM
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz Ggmbh
  • Georgsmarienhütte, Germany, 49124
    • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
• Greece
  • Athens, Greece, 185 47
    • Metropolitan Hospital
  • Thessaloniki, Greece, 54007
    • Theageneio Hospital
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Szolnok, Hungary, 5004
    • Hetenyi Geza County Hospital
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
• Italy
  • Campania
    • Naples, Campania, Italy, 80131
      • Az. Osp. Monaldi
  • Lazio
    • Rome, Lazio, Italy, 00151
      • Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1
  • Lombardy
    • Milan, Lombardy, Italy, 20141
      • Irccs Istituto Europeo Di Oncologia (IEO)
  • Piedmont
    • Orbassano, Piedmont, Italy, 10043
      • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hokkaido, Japan, 003-0804
    • National Hospital Organization Hokkaido Cancer Center
  • Hyōgo, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Miyagi, Japan, 981-0914
    • Sendai Kousei Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Japan, 534-0021
    • Osaka City General Hospital
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
• Kazakhstan
  • Almaty, Kazakhstan, 050054
    • Almaty Oncology Center
• North Macedonia
  • Skopje, North Macedonia, 1000
    • PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax
  • Skopje, North Macedonia, 1000
    • Private Health Organization Acibadem Sistina Hospital
• Poland
  • Gda?sk, Poland, 80-214
    • Gdanski Uniwersytet Medyczny
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
  • Olsztyn, Poland, 10-357
    • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
• Romania
  • Cluj-Napoca, Romania, 400015
    • Prof Dr I Chiricuta Institute of Oncology
  • Timișoara, Romania, 300239
    • Oncomed SRL
• Russia
  • Krasnodar, Russia, 350086
    • GUZ Regional clinical hospital # 1
  • Moscow Oblast
    • Moscovskaya Oblast, Moscow Oblast, Russia, 143423
      • Moscow City Oncology Hospital #62
    • Moscow, Moscow Oblast, Russia, 115478
      • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
    • Moscow, Moscow Oblast, Russia, 125284
      • P.A. Gertsen Cancer Research Inst.
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197022
      • Pavlov First Saint Petersburg State Medical University
    • Saint Petersburg, Sankt-Peterburg, Russia, 197022
      • SPb City Clin Onc Dsp
    • Saint Petersburg, Sankt-Peterburg, Russia, 197758
      • Scientific Research Oncology Institute named after N.N. Petrov
• South Korea
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Gyeonggi-do, South Korea, 16499
    • Ajou University Medical Center
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
• Taiwan
  • Kaohsiung City, Taiwan, 00833
    • Chang Gung Memorial Foundation - Kaohsiung
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou
  • Xitun Dist., Taiwan, 40705
    • TaiChung Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe Uni Medical Faculty Hospital
  • Ankara, Turkey (Türkiye), 06500
    • Ankara Ataturk Chest Diseases Training and Research Hospital
  • Istanbul, Turkey (Türkiye), 34300
    • Istanbul Uni Cerrahpasa Medical Faculty Hospital
  • Izmir, Turkey (Türkiye), 35100
    • Ege Uni Medical Faculty Hospital
  • Izmir, Turkey (Türkiye), 35110
    • Izmir Suat Seren Chest Diseases and Surgery Research Hospital
  • Malatya, Turkey (Türkiye), 44280
    • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
  • Samsun, Turkey (Türkiye), 55200
    • Medikal Park Samsun
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • Chemotherapy SI Dnipropetrovsk MA of MOHU
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncological Center
  • Sumy, Ukraine, 40005
    • RCI Sumy Regional Clinical Oncological Dispensary
  • Vinnytsia, Ukraine, 21029
    • Vinnytsia Regional Clinical Oncology Dispensary
  • KIEV Governorate
    • Kapitanovka Village, KIEV Governorate, Ukraine, 08112
      • Medical center of Yuriy Spizhenko LLC
• United Kingdom
  • London, United Kingdom, SE1 9RY
    • Guys Hospital
  • Manchester, United Kingdom, M23 9QZ
    • Wythenshaw Hospital
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MGH Cancer Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • AHN Cancer Institute ? Allegheny General Hospital

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria

• Age ≥18 years
• Complete resection of histologically confirmed Stage IB (tumor ≥ 4 cm) to Stage IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per Union Internationale Contre le Cancer / American Joint Committee on Cancer, 7th edition, with negative margins, at 4-12 weeks before enrollment
• If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred
• Documented ALK-positive disease according to an FDA-approved and CE-marked test
• Eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines
• Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1
• Adequate hematologic and renal function
• For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
• For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy. Men must refrain from donating sperm during this same period
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Key Exclusion Criteria

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
• Prior adjuvant radiotherapy for NSCLC
• Prior exposure to systemic anti-cancer therapy and ALK inhibitors
• Stage IIIA N2 patients that, in the investigator's opinion, should receive post-operative radiotherapy treatment are excluded from the study
• Known sensitivity to any component of study drug to which the patient may be randomized. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption.
• Malignancies other than NSCLC within 5 years prior to enrollment, except for curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, ductal carcinoma in situ, papillary thyroid cancer, or any cured cancer that is considered to have no impact on disease free survival or overall survival for the current NSCLC
• Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
• Liver disease characterized by aspartate transaminase and alanine transaminase >= 3 × upper limit of normal or impaired excretory function or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices or active viral or active autoimmune, alcoholic, or other types of acute hepatitis
• Japanese patients participating in the serial/intensive PK sample collection only: administration of strong/potent CYP450 3A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib up to Week 3
• Any exclusion criteria based on the local labels or guidelines for chemotherapy regimen
• Patients with symptomatic bradycardia
• History of organ transplant
• Known HIV positivity or AIDS-related illness
• Any clinically significant concomitant disease or condition that could interfere with-or for which the treatment might interfere with the conduct of the study or the absorption of oral medications or that would pose an unacceptable risk to the patients in this study, in the opinion of the Principal Investigator
• Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alectinib	Drug: Alectnib; Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first.; Other Names: RO5424802
Active Comparator: Platinum-Based Chemotherapy	Drug: Cisplatin; Participants will receive Cisplatin 75 milligrams per square meter (mg/m^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."; Drug: Vinorelbine; Participants will receive Vinorelbine 25 mg/m^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.; Other Names: Navelbine; Drug: Gemcitabine; Participants will receive Gemcitabine 1250 mg/m^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.; Other Names: Gitrabin; Drug: Pemetrexed; Participants will receive 500 mg/m^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."; Other Names: Alimta®; Drug: Carboplatin; For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS), as Assessed by the Investigator	DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first	Approximately 58 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI. OS, defined as the time from randomization to death from any cause.	From the date of randomization until death due to any cause up to approximately 8 years
Percentage of Participants With Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.	Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.	Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
Plasma Concentration of Alectinib		Predose (2 hours) Week 3 - Week 96
Plasma Concentration of Alectinib Metabolite M4		Predose (2 hours) Week 3 - Week 96

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Lu S, Wang Q, Ochi Lohmann T, Xu T, Cardona A, Ruf T, Noe J, Solomon BJ; ALINA Investigators. Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Apr 11;390(14):1265-1276. doi: 10.1056/NEJMoa2310532.
• Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Lu S, Wang Q, Lohmann TO, Xu T, Cardona A, Hiles L, Noe J, Solomon BJ. Plain language summary of the ALINA study results: alectinib compared with chemotherapy after surgery in people with ALK-positive non-small cell lung cancer. Future Sci OA. 2025 Dec;11(1):2578145. doi: 10.1080/20565623.2025.2578145. Epub 2025 Nov 11.
• Barlesi F, Ahn JS, Solomon BJ, Nishio M, Dziadziuszko R, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Xu T, Bara I, Ding B, Ngiam C, Petric P, Wu YL. Disease characteristics and treatment outcomes in patients with resected early-stage ALK-positive non-small cell lung cancer from the randomized ALINA trial. Lung Cancer. 2026 Mar 28;216:109385. doi: 10.1016/j.lungcan.2026.109385. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): June 26, 2023
• Study Completion (Estimated): November 19, 2031

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC, alectinib, ALK positive,adjuvant treatment, platinum based chemotherapy, complete resection, Stage IB-IIIA.
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Indoles; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Platinum Compounds; Vinorelbine; Pemetrexed; Gemcitabine; Carboplatin; Cisplatin; alectinib
• Other Study ID Numbers: BO40336; 2017-004331-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

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