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New targeted therapy shows promise for rare lung cancer subtype

NCT ID NCT04194944

Disease control Sponsor: Eli Lilly and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called selpercatinib against standard chemotherapy for people with a certain type of advanced lung cancer (RET fusion-positive non-small cell lung cancer). The goal is to see if selpercatinib can delay cancer growth better than current treatments. About 261 participants will receive either selpercatinib or standard therapy, and those on standard therapy may switch to selpercatinib if their cancer worsens.

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

261 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Jun 2030

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: * Histologically or cytologically confirmed, Stage IIIB-IIIC or Stage IV non-squamous NSCLC that is not suitable for radical surgery or radiation therapy. * A RET gene fusion in tumor and/or blood from a qualified laboratory. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Adequate hematologic, hepatic and renal function. * Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of treatment and for 6 months after. * Ability to swallow capsules. Exclusion Criteria: * Additional validated oncogenic drivers in NSCLC if known. * Prior systemic therapy for metastatic disease. Treatment (chemotherapy, immunotherapy, or biological therapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at least 6 months prior to randomization. * Major surgery within 3 weeks prior to planned start of selpercatinib. * Radiotherapy for palliation within 1 week of the first dose of study treatment or any radiotherapy within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung. * Symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or untreated spinal cord compression. * Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds. * Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. * Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. * Pregnancy or lactation. * Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently active. * Uncontrolled, disease related pericardial effusion or pleural effusion. * Requiring chronic treatment with steroids. Exclusion Criteria for Participants Receiving Pembrolizumab: * History of interstitial lung disease or interstitial pneumonitis. * Active autoimmune disease or any illness or treatment that could compromise the immune system.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma RET fusion positive cancer

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

  • "Oncolife" LLC

    Zaporizhya, Zaporizhzhia Oblast, 69059, Ukraine

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, 20162, Italy

  • AZ Delta

    Roeselare, West Flanders, 8800, Belgium

  • AZ Nikolaas

    Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium

  • AZ Sint-Maarten, Campus Leopoldstraat 2

    Mechelen, 2800, Belgium

  • Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

    Ankara, 6200, Turkey (Türkiye)

  • Actualidad Basada en la Investigación del Cáncer

    Guadalajara, Jalisco, 44680, Mexico

  • Acıbadem Maslak Hastanesi

    Sariyer, 34457, Turkey (Türkiye)

  • Alexander Fleming

    Ciudad de Buenos Aires, C1426ANZ, Argentina

  • Amsterdam UMC, locatie VUmc

    Amsterdam, 1081 HV, Netherlands

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045, Russia

  • Asan Medical Center

    Seoul, Korea, 05505, South Korea

  • Asklepios Fachkliniken München-Gauting

    Gauting, Bavaria, 82131, Germany

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385, France

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152, Italy

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, 83100, Italy

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Torino, 10043, Italy

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Adana, 1250, Turkey (Türkiye)

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142, China

  • Boramae Medical Center

    Dongjak-gu, Seoul-teukbyeolsi [Seoul], 07061, South Korea

  • Buddhist Dalin Tzu Chi General Hospital

    Dalin Town, Chiayi, 622, Taiwan

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, 5000, Belgium

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, Galicia [Galicia], 15706, Spain

  • CNPE "Regional Center of Oncology"

    Kharkiv, Kharkiv Oblast, 61070, Ukraine

  • Cabinet Medical Oncomed

    Timișoara, Timiș County, 300239, Romania

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

    Clermont-Ferrand, Puy-de-Dôme, 63011, France

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69373, France

  • Centro de Oncología e Investigación de Buenos Aires

    Berazategui, Buenos Aires, B1884BBF, Argentina

  • Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA

    Rio de Janeiro, 22250-905, Brazil

  • Chang Gung Memorial Hospital - Linkou

    Guei Shan Township, Taoyuan County, 333, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung City, 83301, Taiwan

  • Changhua Christian Hospital

    Changhua County, Changhua, 50006, Taiwan

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, China

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12203, Germany

  • Chi Mei Hospital - Liouying Branch

    Tainan, 73657, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Chu Grenoble Alpes

    La Tronche, Isère, 38700, France

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • City Hospital, Nottingham University Hospitals

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Clinica Universitaria De Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE, Argentina

  • Clínica El Castaño

    San Juan, 5400, Argentina

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

    Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

  • Complejo Hospitalario de Jaén

    Jaén, 23007, Spain

  • Complejo Hospitalario de Navarra

    Pamplona, 31009, Spain

  • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

    Constanța, Constanța County, 900591, Romania

  • Cro-Irccs

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dicle Üniversitesi

    Diyarbakır, 21100, Turkey (Türkiye)

  • E-Da hospital

    Kaohsiung City, 82445, Taiwan

  • Ege Universitesi Hastanesi

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, 3015 CE, Netherlands

  • European Interbalkan Medical Center

    Thessaloniki, Thessaloníki, 570 01, Greece

  • Fakultni nemocnice Bulovka

    Prague, 180 81, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • First Affiliated Hosp of College of Med, Zhejiang University

    Hangzhou, 310003, China

  • First Moscow State Medical University I.M. Sechenov

    Moscow, 119991, Russia

  • First affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510080, China

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

  • Franziskus-Hospital Harderberg

    Georgsmarienhütte, Lower Saxony, 49124, Germany

  • Fundacion CENIT para la Investigacion en Neurociencias

    Caba, Buenos Aires, 1125, Argentina

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • G. Papanikolaou General Hospital

    Thessaloniki, Thessaloníki, 570 10, Greece

  • GBUZ Republican Clinical Oncological Dispensary

    Ufa, Baškortostan, Respublika, 450054, Russia

  • Gachon University Gil Medical Center

    Incheon, Korea, 21565, South Korea

  • Gral Medical Diagnostic Center

    Bucharest, Bucharest, 031422, Romania

  • Grupo COI - Clínicas Oncológicas Integradas

    Rio de Janeiro, Rio de Janeiro, 22775-001, Brazil

  • Gyeongsang National University Hospital

    Jinju, Kyǒngsangnam-do, 52727, South Korea

  • Hacettepe University Faculty of Medicine

    Ankara, 6230, Turkey (Türkiye)

  • Hadassah Medical

    Moscow, 121205, Russia

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Health Pharma Professional Research S.A. de C.V:

    Mexico City, Federal District, 03100, Mexico

  • Hong Kong United Oncology Centre

    Jordan, Kowloon, 999077, Hong Kong

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris, 75014, France

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Fundacion Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Insular de Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

  • Hospital Regional Universitario

    Málaga, 29011, Spain

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Sírio Libanês

    São Paulo, Brazil, 01308-060, Brazil

  • Hospital Sírio Libanês

    São Paulo, 01308-060, Brazil

  • Hospital Universitari Dexeus

    Barcelona, 08028, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital de Cancer de Londrina

    Londrina, Paraná, 86015-520, Brazil

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • Humanitas

    Rozzano, Milano, 20089, Italy

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005, China

  • IRCCS - AOU di Bologna

    Bologna, 40138, Italy

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246000, Brazil

  • Inonu Universitesi Turgut Ozal Tıp Merkezi

    Malatya, 44280, Turkey (Türkiye)

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Institut Régional du Cancer Montpellier

    Montpellier, Hérault, 34298, France

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    São Paulo, São Paulo, 04543-000, Brazil

  • Instituto Nacional de Câncer - INCA

    Rio de Janeiro, 20231-050, Brazil

  • Institutul Oncologic

    Bucharest, Bucharest, 22328, Romania

  • Institutul Oncologic

    Cluj-Napoca, 400015, Romania

  • Istanbul Medeniyet University

    Istanbul, 34722, Turkey (Türkiye)

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, Campania, 80131, Italy

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Izmir Medical Park Hospital

    Izmir, 9035575, Turkey (Türkiye)

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550, Japan

  • Jeroen Bosch Hospital

    's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

  • Jilin Cancer Hospital

    Changchun, Jilin, China

  • Kaluga Regional Clinical Oncology Center

    Kaluga, Kalužskaja Oblast, 248007, Russia

  • Kanagawa cancer center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kindai University Hospital- Osakasayama Campus

    Osaka Sayama-shi, Osaka, 589 8511, Japan

  • Klinikverbund Kempten-Oberallgäu

    Immenstadt im Allgäu, Bavaria, 87509, Germany

  • Konyang University Hospital

    Daejeon, 35365, South Korea

  • LungenClinic Grosshansdorf

    Großhansdorf, Schleswig-Holstein, 22927, Germany

  • Medical Center "Mriya Med-Service", LLC

    Kryvyi Rig, 50000, Ukraine

  • Memorial Antalya Hastanesi

    Antalya, 7090, Turkey (Türkiye)

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council

    Lutsk, Volyn Oblast, 43018, Ukraine

  • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University"

    Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

  • Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T

    Kyiv, 03115, Ukraine

  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council

    Odesa, 65025, Ukraine

  • Murmansk Regional Clinical Hospital P.A. Bayandina

    Murmansk, Murmansk Oblast, 183047, Russia

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • National Cancer Center

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

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704, Taiwan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • Nemocnice AGEL Ostrava - Vitkovice a.s.

    Ostrava - Vitkovice, 70384, Czechia

  • Núcleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-070, Brazil

  • Odessa Regional Oncology Center

    Odesa, Odesa Oblast, 65055, Ukraine

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Oncologico Potosino, S.C.

    San Luis Potosí City, 78209, Mexico

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Ospedale San Gerardo-ASST Monza

    Monza, Lombardy, 20900, Italy

  • Ospedale Santa Maria delle Croci

    Ravenna, Emilia-Romagna, 48121, Italy

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, 08003, Spain

  • Peninsula Oncology Centre

    Frankston, 3199, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Prince of Wales Hospital

    Shatin, 852, Hong Kong

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rambam Health Care Campus

    Haifa, Ḥeifā, 3109601, Israel

  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"

    Chernivtsi, 58013, Ukraine

  • Republican Clinical Oncology Dispensary

    Kazan', 420029, Russia

  • Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (oncological) named afte -T

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Samara Regional Clinical Oncology Center

    Samara, Samara Oblast, 443031, Russia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Scientific research institution of oncology named after N.N. Petrov

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Seoul National University Bundang Hospital

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

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433, China

  • Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • Soroka Medical Center

    Beersheba, 8400000, Israel

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, Attikí, 115 27, Greece

  • Spitalul Județean Sfântul Ioan cel Nou Suceava

    Suceava, 720237, Romania

  • Spitalul Universitar de Urgență București

    Bucharest, 050098, Romania

  • St Vincent's Hospital

    Melbourne, Victoria, 3065, Australia

  • Sumy regional clinical oncological dispensary

    Sumy, Sumska Oblast, 40022, Ukraine

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 235, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • The First Affiated Hospital Of Guangzhou Medical Collage

    Guangzhou, Guangzhou, 510120, China

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Tominaga Hospital

    Nakatogari, Shizuoka, 411-8777, Japan

  • Tottori University Hospital

    Yonago, Tottori, 683-8504, Japan

  • Trakya University

    Edirne, 22030, Turkey (Türkiye)

  • Tri-Service General Hospital

    Neihu Taipei, 114, Taiwan

  • UZ Brussel

    Brussels, Bruxelles-Capitale, Région de, 1090, Belgium

  • UZ Gent Hospital

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University General Hospital of Heraklion

    Heraklion, Krítí, 711 10, Greece

  • University Hospital of Cologne

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsmedizin Göttingen

    Göttingen, Lower Saxony, 37075, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022, China

  • Xinjiang Medical University Cancer Hospital - Urumqi

    Ürümqi, Xinjiang, 830000, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

  • Ziekenhuis St. Jansdal

    Harderwijk, Gelderland, 3844 DG, Netherlands

  • zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi

    Izmir, 35360, Turkey (Türkiye)

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