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New drug alectinib outperforms standard therapy in asian lung cancer patients

NCT ID NCT02838420

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested alectinib against crizotinib in 187 Asian patients with advanced ALK-positive non-small cell lung cancer who had not received prior treatment. Patients took either alectinib or crizotinib capsules twice daily. The study found that alectinib significantly improved progression-free survival compared to crizotinib, suggesting it may be a better first-line option for this population.

What this could mean

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

Active substance
alectinib (a targeted cancer drug taken as a capsule)
What this could lead to
If successful, alectinib could become a standard first treatment for Asian patients with ALK-positive lung cancer, offering better control of the disease.
What could go wrong
This trial is completed and showed positive results, but it only included Asian patients, so findings may not apply to other populations. Side effects like liver problems or lung inflammation are possible.

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

187 people

The number who actually took part.

Started

Aug 2016

Finished

May 2026

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: * Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test. Sufficient tumor tissue available to perform ALK IHC is required. Ventana IHC testing will be performed at the designated central laboratory * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 * No history of receiving systemic treatment for advanced, recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC * Adequate hematologic function: Platelet count greater than equal to (\>=) 100×10\^9 per liter (/L); absolute neutrophil count (ANC) \>=1500 cells per microliter (cells/mcL); hemoglobin\>=9.0 grams per deciliter (g/dL) * Adequate renal function: an estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) formula of \>=45 milliliters per minute per 1.73 square meter * Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before receiving the first dose of study treatment * Measurable disease (by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) before administration of study treatment * Previous brain or leptomeningeal metastases are allowed if the participant is asymptomatic (e.g., diagnosed incidentally at study baseline). Asymptomatic central nervous system (CNS) lesions may be treated at the discretion of the investigator as per local clinical practice. If participant has neurological symptoms or signs because of CNS metastasis, the participant must complete whole-brain radiation or gamma knife irradiation treatment. In all cases, radiation treatment must be completed \>=14 days before enrollment and disease must be clinically stable * For all females of childbearing potential, a negative serum pregnancy test result must be obtained within 3 days prior to starting study treatment * For women who are not postmenopausal (\>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus), agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the last dose of study drug. Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Examples of contraceptive methods with a failure rate of \<1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of \<1% per year. Barrier methods must always be supplemented with the use of a spermicide * For men, agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the last dose of study drug. Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception Exclusion Criteria: * A malignancy within the previous 3 years (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact in progression-free survival (PFS) or overall survival (OS) 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: * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than (\>) 3× the upper limit of normal (ULN; \>=5×ULN for participants with concurrent liver metastases) confirmed on two consecutive measurements; or * Impaired excretory function (e.g., hyperbilirubinemia), synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices; or * Acute viral or active autoimmune, alcoholic, or other types of hepatitis * National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Grade 3 or higher toxicities because of any previous therapy (e.g., radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication * History of organ transplant * Co-administration of anti-cancer therapies other than those administered in this study * Baseline QTc \>470 ms or symptomatic bradycardia * Administration of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the receiving the first dose of study treatment and during treatment with alectinib or crizotinib * Administration of agents with potential QT interval prolonging effects within 14 days prior to receiving the first dose of study drug * History of hypersensitivity to any of the additives in the alectinib or crizotinib drug formulation * Pregnant or lactating * Known human immunodeficiency virus (HIV-positivity or acquired immunodeficiency syndrome (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, in the opinion of the Principal Investigator, pose an unacceptable risk to the participant in this study * Any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol requirements or follow-up procedures; those conditions should be discussed with the participant before study entry

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Beijing Chest Hospital

    Beijing, 101149, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Guangdong General Hospital

    Guangzhou, 510080, China

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Jiangsu Cancer Hospital

    Nanjing, 210009, China

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Shanghai chest hospital

    Shanghai, 200030, China

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060, China

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • the First Hospital of Jilin University

    Changchun, 130021, China