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New lung cancer pill shows promise in Head-to-Head trial

NCT ID NCT02075840

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tested alectinib against crizotinib in 303 people with advanced ALK-positive non-small cell lung cancer who had not received prior treatment. Participants took one of the two drugs twice daily until their cancer worsened or side effects became too severe. The main goal was to see which drug better delayed cancer growth.

What this could mean

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

Active substance
Alectinib (drug)
What this could lead to
If alectinib works better than crizotinib, it could become a new first-choice treatment for people with ALK-positive lung cancer, helping them live longer without their cancer growing.
What could go wrong
This is a completed phase 3 trial, so results are more reliable, but alectinib may still have side effects or not work for everyone. It is not a cure, and patients will need to keep taking the drug indefinitely.

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

303 people

The number who actually took part.

Started

Aug 2014

Finished

Apr 2025

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 * Life expectancy of at least 12 weeks * Eastern cooperative oncology group performance status (ECOG PS) of 0-2 * Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC * Adequate renal, and hematologic function * Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment * Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment * Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline) * Negative pregnancy test for all females of child bearing potential * Use of highly effective contraception as defined by the study protocol Exclusion Criteria: * Participants with a previous malignancy within the past 3 years * Any gastrointestinal (GI) disorder or liver disease * National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia) * History of organ transplant * Co-administration of anti-cancer therapies other than those administered in this study * Participants with baseline QTc greater than (\>) 470 milliseconds or symptomatic bradycardia * Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment * Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only * History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation * Pregnancy or lactation * Any clinically significant disease or condition (or history of) 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 potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry

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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.

Non-small cell lung cancer

Contacts and locations

Locations

  • A.O. Universitaria Di Parma

    Parma, Emilia-Romagna, 43100, Italy

  • Ankara University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima

    Catania, Sicily, 95122, Italy

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    Perugia, Umbria, 06156, Italy

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

    Adana, 01250, Turkey (Türkiye)

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts, 02215, United States

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • CHRU de Lille

    Lille, 59037, France

  • CHUC - Unidade de Pneumologia Oncológica

    Coimbra, 3000-075, Portugal

  • CHUV

    Lausanne, 1011, Switzerland

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Centre Leon Berard

    Lyon, 69373, France

  • Centro Internacional de Estudios Clínicos (CIEC)

    Santiago, 8420383, Chile

  • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie

    Warsaw, 02-781, Poland

  • Chiang Rai Prachanukroh Hospital

    Chiang Rai, 57000, Thailand

  • Chu Grenoble - Hopital Albert Michallon

    Grenoble, 38043, France

  • Clinica CIMCA

    San José, DUMMY_VALUE, Costa Rica

  • Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Can Ins

    Boston, Massachusetts, 02215, United States

  • Grupo Angeles

    Guatemala City, 01015, Guatemala

  • Guys & St Thomas Hospital

    London, SE1 9RT, United Kingdom

  • Hopital Haut Leveque

    Pessac, 33604, France

  • Hospital General Univ. de Alicante

    Alicante, 3010, Spain

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916, Spain

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • IPO de Lisboa

    Lisbon, 1099-023, Portugal

  • IPO do Porto

    Porto, 4200-072, Portugal

  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

    Malatya, 44280, Turkey (Türkiye)

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Institute for pulmonary diseases of Vojvodina

    Kamenitz, 21204, Serbia

  • Instituto Nacional De Enfermedades Respiratorias

    Mexico City, Mexico CITY (federal District), 14080, Mexico

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Irccs Ist. Tumori Giovanni Paolo Ii

    Bari, Apulia, 70124, Italy

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milan, Lombardy, 20141, Italy

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133, Italy

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Kasr Eieny Uni Hospital

    Cairo, 11555, Egypt

  • Khonkaen Hospital

    Khonkaen, 40000, Thailand

  • King Chulalongkorn Memorial Hospital

    Patumwan, 10330, Thailand

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010, Australia

  • Kyiv Regional Oncological Dispensary

    Kyiv, 04107, Ukraine

  • Lviv State Oncology Regional Treatment and Diagnostic Centre

    Lviv, 79031, Ukraine

  • Meir Medical Center

    Kfar Saba, 44281, Israel

  • Monash Health Translational Precinct

    Victoria, Victoria, 3168, Australia

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423, Russia

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

    Lublin, 20-064, Poland

  • N.N.Burdenko Main Military Clinical Hospital

    Moscow, 105229, Russia

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • National Cancer Centre

    Singapore, 169610, Singapore

  • National Cancer Inst.

    Bangkok, 10400, Thailand

  • National Cheng Kung Univ Hosp

    Tainan, 00704, Taiwan

  • National Taiwan University Hospital

    Taipei, 00100, Taiwan

  • National University Hospital

    Singapore, 119228, Singapore

  • North Valley Hem Onc Med Grp

    Northridge, California, 91325, United States

  • Ospedale Provinciale Santa Maria Delle Croci

    Ravenna, Emilia-Romagna, 48100, Italy

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, DUMMY_VALUE, Hong Kong

  • Policlinico Umberto i di Roma

    Rome, Lazio, 00161, Italy

  • Prince of Wales Hosp

    Hong Kong, Hong Kong

  • Princess Margaret Hospital

    Hong Kong, DUMMY_VALUE, Hong Kong

  • Queen Elizabeth Hospital

    Adelaide, South Australia, 5011, Australia

  • Queen Mary Hospital

    Hong Kong, DUMMY_VALUE, Hong Kong

  • Rambam Medical Center

    Haifa, 4959381, Israel

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • SPb City Clin Onc Dsp

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Scientific Research Oncology Institute named after N.N. Petrov

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060, China

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

  • TMPN/ Cancer Care Associates

    Redondo Beach, California, 90277, United States

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 00112, Taiwan

  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

    Edirne, 22770, Turkey (Türkiye)

  • Tuen Mun Hospital

    Hong Kong, 852, Hong Kong

  • Uni of Auckland

    Auckland, DUMMY_VALUE, New Zealand

  • Universitaetsspital Basel

    Basel, 4031, Switzerland

  • University Clinical Center Sarajevo

    Sarajevo, 71000, Bosnia and Herzegovina

  • University College London Hospital

    London, NW1 - 2PG, United Kingdom

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • University of Miami-Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UniversitätsSpital Zürich

    Zurich, 8091, Switzerland

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357, Poland

  • Washington Uni School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.