TriangleNCT03456076 · CITED IN SOURCE DOCUMENTS
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-15
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.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Disease-free Survival (DFS), as Assessed by the Investigator
Overall Survival (OS)
Percentage of Participants With Adverse Events (AEs)
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms
Plasma Concentration of Alectinib
Plasma Concentration of Alectinib Metabolite M4
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Alectnib
- label
- Alectinib
- type
- EXPERIMENTAL
- intervention Names
- Drug: Cisplatin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Pemetrexed
- Drug: Carboplatin
- label
- Platinum-Based Chemotherapy
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Alectinib
- description
- 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.
- name
- Alectnib
- other Names
- RO5424802
- type
- DRUG
- arm Group Labels
- Platinum-Based Chemotherapy
- description
- 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."
- name
- Cisplatin
- type
- DRUG
- arm Group Labels
- Platinum-Based Chemotherapy
- description
- 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.
- name
- Vinorelbine
- other Names
- Navelbine
- type
- DRUG
- arm Group Labels
- Platinum-Based Chemotherapy
- description
- 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.
- name
- Gemcitabine
- other Names
- Gitrabin
- type
- DRUG
- arm Group Labels
- Platinum-Based Chemotherapy
- description
- 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."
- name
- Pemetrexed
- other Names
- Alimta®
- type
- DRUG
- arm Group Labels
- Platinum-Based Chemotherapy
- description
- For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.
- name
- Carboplatin
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 257
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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
- measure
- Disease-free Survival (DFS), as Assessed by the Investigator
- time Frame
- Approximately 58 months
- secondary Outcomes
- description
- 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.
- measure
- Overall Survival (OS)
- time Frame
- From the date of randomization until death due to any cause up to approximately 8 years
- description
- 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.
- measure
- Percentage of Participants With Adverse Events (AEs)
- time Frame
- 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)
- description
- 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.
- measure
- AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms
- time Frame
- 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)
- measure
- Plasma Concentration of Alectinib
- time Frame
- Predose (2 hours) Week 3 - Week 96
- measure
- Plasma Concentration of Alectinib Metabolite M4
- time Frame
- Predose (2 hours) Week 3 - Week 96
Full study description
- 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.
Source references
- references
- citation
- Dziadziuszko R, Ahn JS, Barlesi F, Solomon BJ, Wu YL, Bondarenko I, Hochmair M, Horinouchi H, Lee DH, Lee JS, Planchard D, Rittmeyer A, Zhong W, Adler L, Archer V, Cardona A, Petric P, Scalori A, Ding B, Mamolo C, Smoljanovic V, Nishio M. Adjuvant alectinib versus chemotherapy in resected ALK-positive non-small-cell lung cancer (ALINA): health-related quality-of-life and safety outcomes from a randomised, open-label, phase 3 trial. Lancet Oncol. 2026 Sep;27(9):1110-1119. doi: 10.1016/S1470-2045(26)00283-4.
- pmid
- 42636834
- type
- DERIVED
- citation
- 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 Jun;216:109385. doi: 10.1016/j.lungcan.2026.109385. Epub 2026 Mar 28.
- pmid
- 41996761
- type
- DERIVED
- citation
- 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
- type
- DERIVED
- citation
- 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
- type
- DERIVED
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- Updated: May 15, 2025
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Preserved source evidence · Not medical advice