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

NCT03456076 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 2 other identifiers: BO403362017-004331-37
• Study Type: interventional
• Target: 257
• Locations: 26 countries
• Sites: 113

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC, alectinib, ALK positive,adjuvant treatment, platinum based chemotherapy, complete resection, Stage IB-IIIA.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival (OS)

  From the date of randomization until death due to any cause up to approximately 8 years

• Percentage of Participants With Adverse Events (AEs)

  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

  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

Study Arms (2)

Alectinib

EXPERIMENTAL

Drug: Alectnib

Platinum-Based Chemotherapy

ACTIVE COMPARATOR

Drug: Cisplatin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Carboplatin

Interventions

Pemetrexed DRUG

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."

Also known as: Alimta®

Platinum-Based Chemotherapy

Carboplatin DRUG

For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.

Platinum-Based Chemotherapy

Alectnib DRUG

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.

Also known as: RO5424802

Alectinib

Cisplatin DRUG

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."

Platinum-Based Chemotherapy

Vinorelbine DRUG

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.

Also known as: Navelbine

Platinum-Based Chemotherapy

Gemcitabine DRUG

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.

Also known as: Gitrabin

Platinum-Based Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (114)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MGH Cancer Center

Boston, Massachusetts, 02114, United States

Location

AHN Cancer Institute ? Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

GenesisCare North Shore

St Leonards, New South Wales, 2065, Australia

Location

Peter MacCallum Cancer Center

Melbourne, Victoria, 3000, Australia

Location

Krankenhaus Nord - Klinik Floridsdorf

Vienna, 1210, Austria

Location

Healthcare Institution Grodno University Hospital

Hrodna, Grodnenskaya, 230030, Belarus

Location

Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?

Homyel, Homyel'skaya Voblasts', 246012, Belarus

Location

Vitebsk Regional Clinical Oncology Dispensary

Vitebsk, Vitebsk Oblast, BU-210603, Belarus

Location

Clinical center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Jilin Cancer Hospital

Changchun, 132013, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Fujian Medical University Union Hospital

Fujian, 350001, China

Location

Guangdong General Hospital

Guangzhou, 510080, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Shandong Cancer Hospital

Jinan, 250117, China

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Shenzhen People's Hospital

Shenzhen, 510852, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430023, China

Location

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, 710061, China

Location

Odense Universitetshospital, Onkologisk Afdeling R

Odense C, 5000, Denmark

Location

Kasr Eieny Uni Hospital

Cairo, 11555, Egypt

Location

CHU Angers

Angers, 49933, France

Location

Hopital Nord AP-HM

Marseille, 13015, France

Location

Hopital Bichat Claude Bernard

Paris, 75018, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

Georgsmarienhütte, 49124, Germany

Location

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

Fachklinik für Lungenerkrankungen

Immenhausen, 34376, Germany

Location

Metropolitan Hospital

Athens, 185 47, Greece

Location

Theageneio Hospital

Thessaloniki, 54007, Greece

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

Hetenyi Geza County Hospital

Szolnok, 5004, Hungary

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Az. Osp. Monaldi

Naples, Campania, 80131, Italy

Location

Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

Rome, Lazio, 00151, Italy

Location

Irccs Istituto Europeo di Oncologia (IEO)

Milan, Lombardy, 20141, Italy

Location

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont, 10043, Italy

Location

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

Perugia, Umbria, 06156, Italy

Location

Aichi Cancer Center

Aichi, 464-8681, Japan

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Hokkaido, 003-0804, Japan

Location

National Hospital Organization Himeji Medical Center

Hyōgo, 670-8520, Japan

Location

Kanagawa Cancer Center

Kanagawa, 241-8515, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Sendai Kousei Hospital

Miyagi, 981-0914, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Almaty Oncology Center

Almaty, 050054, Kazakhstan

Location

PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

Skopje, 1000, North Macedonia

Location

Private Health Organization Acibadem Sistina Hospital

Skopje, 1000, North Macedonia

Location

Gdanski Uniwersytet Medyczny

Gda?sk, 80-214, Poland

Location

Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

Krakow, 31-202, Poland

Location

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, 10-357, Poland

Location

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, 60-569, Poland

Location

Prof Dr I Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

Oncomed SRL

Timișoara, 300239, Romania

Location

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, 143423, Russia

Location

FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

Moscow, Moscow Oblast, 115478, Russia

Location

P.A. Gertsen Cancer Research Inst.

Moscow, Moscow Oblast, 125284, Russia

Location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

SPb City Clin Onc Dsp

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

Scientific Research Oncology Institute named after N.N. Petrov

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

GUZ Regional clinical hospital # 1

Krasnodar, 350086, Russia

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Ajou University Medical Center

Gyeonggi-do, 16499, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Chang Gung Memorial Foundation - Kaohsiung

Kaohsiung City, 00833, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang Gung Medical Foundation - Linkou

Taoyuan, 333, Taiwan

Location

Taichung Veterans General Hospital

Xitun Dist., 40705, Taiwan

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Ataturk Chest Diseases Training and Research Hospital

Ankara, 06500, Turkey (Türkiye)

Location

Istanbul Uni Cerrahpasa Medical Faculty Hospital

Istanbul, 34300, Turkey (Türkiye)

Location

Ege Uni Medical Faculty Hospital

Izmir, 35100, Turkey (Türkiye)

Location

Izmir Suat Seren Chest Diseases and Surgery Research Hospital

Izmir, 35110, Turkey (Türkiye)

Location

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, 44280, Turkey (Türkiye)

Location

Medikal Park Samsun

Samsun, 55200, Turkey (Türkiye)

Location

Medical center of Yuriy Spizhenko LLC

Kapitanovka Village, KIEV Governorate, 08112, Ukraine

Location

Chemotherapy SI Dnipropetrovsk MA of MOHU

Dnipropetrovsk, 49102, Ukraine

Location

Kyiv City Clinical Oncological Center

Kyiv, 03115, Ukraine

Location

RCI Sumy Regional Clinical Oncological Dispensary

Sumy, 40005, Ukraine

Location

Vinnytsia Regional Clinical Oncology Dispensary

Vinnytsia, 21029, Ukraine

Location

Guys Hospital

London, SE1 9RY, United Kingdom

Location

Wythenshaw Hospital

Manchester, M23 9QZ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 41996761 DERIVED

• 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.

  PMID: 41217067 DERIVED

• 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.

  PMID: 38598794 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

alectinib; Cisplatin; Vinorelbine; Gemcitabine; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 7, 2018
• Study Start: August 16, 2018
• Primary Completion: June 26, 2023
• Study Completion (Estimated): November 19, 2031
• Last Updated: May 5, 2026
• Results First Posted: August 26, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (3); IL (2); HU (2); PL (4); CN (12); RO (2); EG (1); KR (8); UA (5); KA (1); ES (6); TW (5); TH (2); NO (2); DK (1); TU (8); GB (2); IT (5); AU (3); FR (4); GR (2); US (3); DE (4); BO (1); JP (18); RU (7)