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New pill takes on chemo for rare lung cancer

NCT ID NCT04129502

Disease control Sponsor: Takeda 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares a new oral targeted drug, TAK-788 (mobocertinib), against standard chemotherapy as a first treatment for advanced non-small cell lung cancer with a specific EGFR mutation (exon 20 insertion). About 354 adults with this rare mutation will be randomly assigned to receive either the pill or chemo. The main goal is to see if the drug delays cancer growth better than chemo.

What this could mean

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

Active substance
Mobocertinib (TAK-788), a targeted oral drug
What this could lead to
If it works, this could offer a more effective first-line treatment option for people with a specific type of lung cancer that has few targeted therapies.
What could go wrong
This is a late-stage trial, but targeted therapies can still fail to outperform chemotherapy or cause significant side effects. Results may not apply to all patients with this mutation.

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

354 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Oct 2026

An estimate. End dates often move.

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: * Male or female adult patients (aged 18 years or older) * Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC * Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (US sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations for which there are approved anti-EGFR tyrosine kinase inhibitors \[TKIs\] (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid) * Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation * At least 1 measurable lesion per RECIST Version 1.1 * Life expectancy ≥3 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Adequate organ and hematologic function as defined by blood transfusions with a recommended \>/ 14 day washout period. Exclusion Criteria: * Received prior systemic treatment for locally advanced or metastatic disease, including local administration, such as intra-pleural injection of anticancer medication with the exception noted below: * Neoadjuvant or adjuvant chemotherapy/immune therapy for Stage I to III or combined modality chemotherapy/radiation for locally advanced disease is allowed if completed \>6 months before the development of metastatic disease. * Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities * Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before first dose of TAK-788 * Have been diagnosed with another primary malignancy other than NSCLC * Have current spinal cord compression or leptomeningeal disease * Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure * Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin * Taking medication(s) known to be associated with the development of torsades de pointes.

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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.

Advanced/metastatic non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • AORN Dei Colli- Ospedale Monaldi Napoli

    Naples, Campania, 80131, Italy

  • AZ Sint-Lucas

    Aalst, Oost-Vlaanderen, 9300, Belgium

  • AdventHealth

    Orlando, Florida, 32804, United States

  • Asan Medical Center - PPDS

    Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56124, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126, Italy

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Baskent University Medical Faculty Adana Practice and Research Center

    Yüreğir, Adana, 01120, Turkey (Türkiye)

  • Beijing Cancer Hospital - PPDS

    Beijing, Beijing Municipality, 100142, China

  • Beijing Cancer Hospital - PPDS

    Beijing, 100142, China

  • Beijing Chest Hospital, Capital Medical Univerity

    Beijing, 101149, China

  • Beth Israel Deaconess Medical Center - 330 Brookline Ave

    Boston, Massachusetts, 02115, United States

  • Bioclinic Thessaloniki (Galinos clinic)

    Thessaloniki, 546 29, Greece

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z-4E6, Canada

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004, Spain

  • CHU de Grenoble

    Grenoble, 38043, France

  • CHU de Nantes - Hoptal Nord Laennec

    Nantes, Loire-Atlantique, 44000, France

  • CRLC Val d'Aurelle - Paul Lamarque

    Montpellier, 34298, France

  • Centre Francois Baclesse

    Caen, Calvados, 14076, France

  • Centre Leon Berard

    Lyon, Rhone, 69373, France

  • Centro Di Riferimento Oncologico

    Aviano, Pordenone, 33081, Italy

  • Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente

    Lisbon, 1769-001, Portugal

  • Centro Hospitalar de Sao Joao, E.P.E.

    Porto, 4200, Portugal

  • Centro Hospitalar do Porto Hospital de Santo Antonio

    Santa Maria da Feira, Aveiro District, 4520-211, Portugal

  • Chi Mei Medical Center, Liouying

    Tainan, 736, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeongnam, 519-763,, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • City of Hope National Medical Center

    Long Beach, California, 90813, United States

  • Clatterbridge Centre For Oncology

    Bebington, Wirral, CH63 4JY, United Kingdom

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200, Belgium

  • Communal Non-profit Enterprise Regional Center of Oncology

    Kharkiv, Kharkiv Oblast, 61070, Ukraine

  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Dalin, 622, Taiwan

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • E-DA hospital

    Kaohsiung City, 82445, Taiwan

  • Ege University Medical Faculty

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Ehime University Hospital

    Matsuyama, Ehime, 791-0280, Japan

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fujita Health University Hospital

    Toyoake-Shi, Aiti, 470-1101, Japan

  • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

    Saint Petersburg, Leningradskaya Oblast', 197758, Russia

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065, Australia

  • Grand Hopital de Charleroi asbl

    Charleroi, Hainaut, 6000, Belgium

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Harbin Medical University Tumor Hospital

    Harbin, 150081, China

  • Helios Klinikum Emil Von Behring

    Berlin, 14165, Germany

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hopital Calmette

    Lille, Nord, 59037, France

  • Hopital Du Sacre Coeur de Montreal

    Montreal, Quebec, H4J 1C5, Canada

  • Hopital Larrey

    Toulouse, 31059, France

  • Hopital Nord AP-HM

    Marseille, 13915, France

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Cuf Porto

    Vila Nova de Gaia, Porto District, 4434-502, Portugal

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario A Coruna

    A Coruña, 15006, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035, Spain

  • Hubei Cancer Hospital

    Wuhan, 430079, China

  • ICO lHospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Icahn School of Medicine at Mount Sinai

    Beijing, China

  • Institut Gustave Roussy

    Villejuif, Val-de-Marne, 94805, France

  • Instituto Europeo Di Oncologia

    Milan, Lombardy, 20141, Italy

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

    Porto, 4200-072, Portugal

  • Istituto Nazionale Dei Tumori

    Milan, Lombardy, 20133, Italy

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

    Meldola, Forli-Cesena, 47014, Italy

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012, China

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-0815, Japan

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Karolinska Universitetssjukhuset Solna

    Stockholm, Södermanland County, Sweden

  • Klinik Floridsdorf

    Vienna, 1210, Austria

  • Kurume University Hospital

    Kurume-Shi, Hukuoka, 830-0011, Japan

  • LLC "EuroCityClinic"

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • LMU Klinikum der Universitat Munchen

    München, Bavaria, 80336, Germany

  • Leicester General Hospital

    Leicester, LE1 5WW, United Kingdom

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115, United States

  • Miyagi Cancer Center

    Natori-shi, Miyagi, 981-1239, Japan

  • Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

    Dnipropetrovsk, Dnipropetrovsk Oblast, 49102, Ukraine

  • National Cancer Center

    Goyang, 410769, South Korea

  • National Cancer Center Hospital East

    Kashiwa-Shi, Chiba, 277-0882, Japan

  • National Cancer Centre

    Singapore, 169608, Singapore

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National Taiwan University Hospital - YunLin Branch

    Douliu, 640, Taiwan

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Nouvel Hopital Civil

    Strasbourg, 67091, France

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-0914, Japan

  • Osaka International Cancer Institute

    Chuo Ku, Osaka, 540-0008, Japan

  • Ospedale Santa Maria Delle Croci

    Ravenna, 48121, Italy

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, Hong Kong

  • Pius Hospital Oldenburg

    Oldenburg, Lower Saxony, 26121, Germany

  • Prince of Wales Hospital

    Shatin, Hong Kong

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Hospital

    Toronto, Ontario, M5G2M9, Canada

  • Princess Margaret Hospital

    Kowloon City, Kowloon City, Hong Kong

  • Private Enterprise Private Manufacturing Company Acinus

    Kropyvnytskyi, 25006, Ukraine

  • Pusan National University Hospital

    Busan, 602-739, South Korea

  • Queen Elizabeth Hospital (QEH)

    Hong Kong, Hong Kong

  • Queen Mary Hospital - PPDS

    Hong Kong, Hong Kong

  • Royal Marsden Hospital - Surrey

    Sutton, Surrey, SM2 5PT, United Kingdom

  • SAKARYA University Medical Faculty

    Karaman, Sakarya, 54290, Turkey (Türkiye)

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4101, Japan

  • Saitama Cancer Center

    Komoro, Saitama, 362-0806, Japan

  • Samsung Medical Center PPDS

    Seoul, 06351, South Korea

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 120-752, South Korea

  • Shanghai East Hospital

    Shanghai, 200123, China

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621, Israel

  • Sichuan Cancer Hospital & Institute

    Chengdu, 610041, China

  • Soroka University Medical Centre

    Beersheba, 84101, Israel

  • Sotiria Chest Hospital of Athens

    Athens, Attica, 11527, Greece

  • Stanford University

    Palo Alto, California, 94304, United States

  • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Kadıköy, Istanbul, 34772, Turkey (Türkiye)

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Koto-Ku, Tokyo, 135-0063, Japan

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

    Seoul, 06591, South Korea

  • The Christie NHS Foundation Trust - PPDS

    Manchester, M20 4GJ, United Kingdom

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, 310003, China

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • Tuen Mun Hospital

    Hong Kong, Hong Kong

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60596, Germany

  • University Clinic Regensburg

    Regensburg, Bavaria, 93053, Germany

  • University College London Hospitals (UCLH)

    London, London, City of, NW1 2PG, United Kingdom

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • VU Medisch Centrum

    Amsterdam, North Holland, 1081 HV, Netherlands

  • William Osler Health System

    Brampton, Ontario, L6R 3J7, Canada

More trials for these conditions

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