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

NCT ID NCT04248829

Disease control Sponsor: Yuhan Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 4 times

Summary

This Phase 3 trial tested a new targeted therapy, lazertinib, against the standard drug gefitinib in 393 people with advanced EGFR-mutated non-small cell lung cancer. The goal was to see if lazertinib could keep cancer from growing longer. Participants took either lazertinib or gefitinib daily, and researchers measured how long until the cancer progressed.

What this could mean

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

Active substance
lazertinib
What this could lead to
If lazertinib works better than gefitinib, it could become a new standard first-line treatment for people with EGFR-mutated lung cancer, potentially delaying cancer growth longer.
What could go wrong
This trial compares two similar drugs, so the improvement may be modest. As a completed Phase 3 study, results are robust, but individual responses vary and side effects 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

393 people

The number who actually took part.

Started

Feb 2020

Finished

Apr 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: * Pathologically confirmed adenocarcinoma of the lung * Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy * At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations * Treatment-naïve for locally advanced or metastatic NSCLC * WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization * At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period Exclusion Criteria: * Symptomatic and unstable brain metastases * Leptomeningeal metastases * Symptomatic spinal cord compression * History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD * Any medical conditions requiring chronic continuous oxygen therapy * History of any malignancy other than the disease under study within 3 years before randomization * Any cardiovascular disease as follows: * History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment * History of myocardial infarction or unstable angina within 24 weeks of randomization

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung 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

  • Adana Baskent Practice and Research Hospital

    Adana, 1120, Turkey (Türkiye)

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Ankara Liv Hospital

    Ankara, 06680, Turkey (Türkiye)

  • Arkhangelsk Regional Clinical Oncological Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Attikon Hospital

    Athens, 12462, Greece

  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

    Omsk, 644013, Russia

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Chiang Mai University - Faculty of Medicine

    Chiang Mai, 50200, Thailand

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • Clinical Hospital Center "Bezanijska Kosa"

    Belgrade, Belgrade, 11080, Serbia

  • Cukurova University Medical Faculty

    Adana, 1330, Turkey (Türkiye)

  • Debreceni Egyetem

    Debrecen, H-4012, Hungary

  • Eugenideio Therapeutirio - Ongcology Department

    Athens, 11528, Greece

  • First St. Petersburg State Medical University n. a. Pavlov

    Saint Petersburg, 197022, Russia

  • GAUZ Republican clinical oncology dispensary of the Ministry

    Kazan', 420029, Russia

  • GBUZ "Regional clinical oncologic dispensary of Volgograd"

    Volgograd, 400138, Russia

  • GBUZ of Nizhny Novgorod region Clinical diagnostic center

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603006, Russia

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • Hacettepe University Medical Faculty - Medical Oncology

    Ankara, 6230, Turkey (Türkiye)

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10400, Malaysia

  • Hospital Raja Perempuan Zainab Ii

    Kota Bharu, Kelantan, 15586, Malaysia

  • Hospital Sultan Ismail

    Johor Bahru, Johor, 81100, Malaysia

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100, Malaysia

  • Hospital Umum Sarawak

    Kuching, Sarawak, 10450, Malaysia

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Inonu University Turgut Ozal Medical Center

    Malatya, 44280, Turkey (Türkiye)

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, Vojvodina, 21204, Serbia

  • Istanbul Medeniyet University Goztepe Training and Research Hospital - Medical Oncology

    Istanbul, 34722, Turkey (Türkiye)

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Keimyung University Dongsan Medical Center

    Daegu, 42601, South Korea

  • Kocaeli University Medical Faculty

    Kocaeli, 41380, Turkey (Türkiye)

  • Komunalne nekomertsiine pidpryiemstvo "Miska klinichna likarnia №4" Dniprvskoi miskoi rady", khimioterapevtychne viddilennia z dennym statsionarom, Derzhavnyi zaklad "Dnipropetrovskyi derzhavnyi medychnyi universitet", kafedra onkolohii i medychnoi radio

    Dnipro, 49102, Ukraine

  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovanyi dyspanser radiatsiinoho zakhystu naselennia" - khirurhichne viddilennia

    Kharkiv, Kharkiv Oblast, 61166, Ukraine

  • Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady "Sumskyi klinichnyi onkolohichnyi tsentr", onkotorakalne viddilennia, Sumskyi derzhavnyi universytet, kafedra onkolohii ta radiolohii, m. Sumy

    Sumy, 40022, Ukraine

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Kyiv City Clinical Oncology Center - Department of Chemotherapy

    Kyiv, 3115, Ukraine

  • LLC "Eurocityclinic"

    Saint Petersburg, 197022, Russia

  • Limited Liability Company "AV Medical Group" - Oncology

    Saint Petersburg, 197082, Russia

  • MBUZ City Clinical Hospital #1

    Novosibirsk, Russia

  • Manila Doctors Hospital - Clinical Trial Office

    Manila, Quezon, 1000, Philippines

  • Medical Point İzmir Hospital

    Izmir, 35560, Turkey (Türkiye)

  • Medincentre (GLAVUPDK)

    Moscow, 119034, Russia

  • Medychnyi tsentr Tovarystva z obmezhenoiu vidpovidalnistiu "Onkolaif"

    Zaporizhzhia, 69059, Ukraine

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr", strukturnyi pidrozdil klinichnoi onkolohii, m.Chernivtsi

    Chernivtsi, 58013, Ukraine

  • Perpetual Succour Hospital

    Cebu, 6000, Philippines

  • Philippine General Hospital

    Manila, 1000, Philippines

  • Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii

    Vinnytsia, 21029, Ukraine

  • Prince of Songkla University

    Hat Yai, 90110, Thailand

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Private medical institution "Euromedservice"

    Pushkin, 196603, Russia

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400, Thailand

  • Republic Clinical Oncology Despensary

    Kazan', 420029, Russia

  • SMG-SNU Boramae Medical Center

    Seoul, 07061, South Korea

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, 198255, Russia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002, Thailand

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-do, 14647, South Korea

  • The Catholic University of Korea, Eunpyeong St.Mary's Hospital

    Seoul, 03312, South Korea

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

  • Theageneio Anticancer Hospital of Thessaloniki

    Thessaloniki, 54007, Greece

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • Tsentralna miska klinichna likarnia

    Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

  • Törökbálinti Tüdőgyógyintézet

    Törökbálint, 2045, Hungary

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • University Malaya Medical Centre

    Kuala Lumpur, Selangor, 59100, Malaysia

  • VitaMed LLC

    Moscow, 121309, Russia

  • Yaroslavl regional oncology hospital

    Yaroslavl, 150054, Russia

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

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