New pill aims to keep HER2 lung cancer from returning after surgery
NCT ID NCT07195695
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 10 times
Summary
This study tests whether a daily pill called zongertinib can help prevent lung cancer from coming back in people with early-stage (Stage II-IIIB) non-small cell lung cancer that has a specific HER2 mutation. All participants have had surgery to remove their tumor and standard chemotherapy. Half will receive zongertinib, and the other half will receive standard care (either immunotherapy or active monitoring). The main goal is to see if zongertinib extends the time before the cancer returns.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Sep 2036
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 2. Patients must be ≥18 years old or over the legal age of consent in their country 3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol 4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations 5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC 6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status 7. Staging: Pretherapeutic classification not exceeding Stage IIIB 8. Performance status and organ function: * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Adequate organ function based on laboratory values Further inclusion criteria apply. Exclusion criteria: 1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56) 2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization 3. Treatment with radiation therapy for primary NSCLC 4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK)) 5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known 6. History or presence of * Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis * Active infectious disease requiring systemic therapy * Uncontrolled gastrointestinal disorders affecting drug intake/absorption * Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers * Significant and/or uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) \>470 msec, or ejection fraction \<50% Further exclusion criteria apply.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
202 sites in 28 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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A.C. Camargo
RECRUITINGSão Paulo, 01509-010, Brazil
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AOU San Luigi Gonzaga
RECRUITINGOrbassano (TO), 10043, Italy
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Adana Şehir Hastanesi
RECRUITINGAdana, Turkey (Türkiye)
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Aichi Cancer Center Hospital
RECRUITINGAichi, Nagoya, 464-8681, Japan
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Ajou University Hospital
RECRUITINGSuwon, 16499, South Korea
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Ankara Bilkent Sehir Hastanesi
NOT_YET_RECRUITINGTürkiye, Turkey (Türkiye)
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Ankara University Medical Faculty Hospital
RECRUITINGAnkara, Turkey (Türkiye)
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Asklepios Fachkliniken München-Gauting
NOT_YET_RECRUITINGGauting, 82131, Germany
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Austin Health
RECRUITINGHeidelberg, 3084, Australia
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Azienda Ospedaliera Universitaria Integrata Verona
RECRUITINGVerona, 37126, Italy
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Beijing Chest Hospital, Capital Medical University
RECRUITINGBeijing, 101149, China
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Bradford Hill- Centro de Investigacion Clinica
RECRUITINGRecoleta, 8420383, Chile
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CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
RECRUITINGSanto André, 09060-650, Brazil
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Cancer Care Specialists
RECRUITINGReno, Nevada, 89511, United States
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Centre Hospitalier Universitaire de Liège
RECRUITINGLiège, 4000, Belgium
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Centre Régional de Lutte Contre le Cancer Paul Stauss
RECRUITINGStrasbourg, 67200, France
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Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
RECRUITINGPorto Alegre, 90110-270, Brazil
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Centro Medico Zambrano Hellion
RECRUITINGMonterrey, 66278, Mexico
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Centro Oncologico Internacional
NOT_YET_RECRUITINGJalisco, 45640, Mexico
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Centro Oncologico Korben
RECRUITINGCABA, 1426, Argentina
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Centro Oncologico Personalizado
NOT_YET_RECRUITINGMéxico, 06760, Mexico
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Centro de Estudios Clinicos SAGA
RECRUITINGProvidencia, 7500653, Chile
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Centro de Infusion Profesional Integral (CIPI)
RECRUITINGMexico City, 14210, Mexico
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Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
RECRUITINGCABA, 1185, Argentina
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Centro de Pesquisa Oncology Natal
RECRUITINGNatal, 59020-400, Brazil
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Chang Gung Memorial Hospital, Linkou
RECRUITINGTaoyuan City, 333, Taiwan
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Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITINGBerlin, 12203, Germany
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Chest Hospital of Athens "Sotiria"
NOT_YET_RECRUITINGAthens, 11527, Greece
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China Medical University Hospital
RECRUITINGTaichung, 40447, Taiwan
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China-Japan Friendship Hospital
RECRUITINGBeijing, 100029, China
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ClinRé 001-022 (Premier Cancer Care and Infusion Center)
RECRUITINGFresno, California, 93710, United States
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Clinic Floridsdorf
RECRUITINGVienna, 1210, Austria
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Clinica Adventista Belgrano
RECRUITINGCABA, 1430, Argentina
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Community Cancer Trials of Utah
RECRUITINGOgden, Utah, 84405, United States
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Complejo Hospitalario de Navarra
RECRUITINGPamplona, 31008, Spain
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Cross Cancer Institute (University of Alberta)
RECRUITINGEdmonton, Alberta, T6G 1Z2, Canada
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
RECRUITINGAnkara, Turkey (Türkiye)
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Duly Health and Care - Lisle
RECRUITINGLisle, Illinois, 60532, United States
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Durham VA Health Care System
NOT_YET_RECRUITINGDurham, North Carolina, 27705, United States
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Flinders Medical Centre
NOT_YET_RECRUITINGBedford Park, South Australia, 5042, Australia
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Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITINGMilan, 20133, Italy
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Fujita Health University Hospital
RECRUITINGAichi, Toyoake, 470-1192, Japan
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Fundación Jiménez Díaz
RECRUITINGMadrid, 28040, Spain
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George Washington University Cancer Center
NOT_YET_RECRUITINGWashington D.C., District of Columbia, 20037, United States
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Guy's Hospital
RECRUITINGLondon, SE1 9RT, United Kingdom
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HOP Nord
RECRUITINGMarseille, 13915, France
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HOP Nord Laennec
RECRUITINGNantes, 44093, France
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HOP Pontchaillou
RECRUITINGRennes, 35033, France
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HOP Tenon - One AP-HP
RECRUITINGParis, 75970, France
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Harbin Medical University Cancer Hospital
RECRUITINGHarbin, 150081, China
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Hebei Provincial Tumor Hospital
RECRUITINGShijiazhuang, 050035, China
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Henan Cancer Hospital
NOT_YET_RECRUITINGZhengzhou, 450008, China
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Hendrick Health
RECRUITINGAbilene, Texas, 79601, United States
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Henry Dunant Hospital, Athens
NOT_YET_RECRUITINGAthens, 11526, Greece
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Hiroshima University Hospital
RECRUITINGHiroshima, Hiroshima, 734-8551, Japan
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Hokkaido Cancer Center
RECRUITINGHokkaido, Sapporo, 003-0804, Japan
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Hopital Louis Pradel
RECRUITINGBron, 69677, France
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Hospital Britanico de Buenos Aires
RECRUITINGCABA, 1280AEB, Argentina
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Hospital CUF Porto
RECRUITINGPorto, 4100-180, Portugal
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Hospital CUF Tejo
RECRUITINGLisbon, 1350-352, Portugal
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Hospital Clinico Universitario de Valencia
RECRUITINGValencia, 46010, Spain
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Hospital General Universitario de Elche
RECRUITINGElche, 03203, Spain
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Hospital Jerez de la Frontera
RECRUITINGJerez de la Frontera, 11407, Spain
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Hospital Puerta de Hierro
RECRUITINGMajadahonda, 28222, Spain
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Hospital Universitari Vall d'Hebron
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario De Burgos
RECRUITINGBurgos, 09006, Spain
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Hospital Universitario Ramon Y Cajal
RECRUITINGMadrid, 28034, Spain
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Hospital Universitario Virgen de la Victoria
RECRUITINGMálaga, 29010, Spain
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Hospital Virgen del Rocio
RECRUITINGSeville, 41013, Spain
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Hospital da Luz
RECRUITINGLisbon, 1500-650, Portugal
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Hospital de Amor
RECRUITINGBarretos, 14784-400, Brazil
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Hospital del Mar
RECRUITINGBarcelona, 08003, Spain
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Hospital of the University of Occupational and Environmental Health
RECRUITINGFukuoka, Kitakyushu, 807-8556, Japan
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Humanitas Istituto Clinico Catanese S.p.A.
RECRUITINGMisterbianco (CT), 95045, Italy
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Hunan Province Tumor Hospital
NOT_YET_RECRUITINGChangsha, 410013, China
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Hôpital Larrey - CHU de Toulouse
RECRUITINGToulouse, 31059, France
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ICESP - Instituto do Cancer do Estado de Sao Paulo
NOT_YET_RECRUITINGSão Paulo, 01246-000, Brazil
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IPO Porto Francisco Gentil, EPE
NOT_YET_RECRUITINGPorto, 4200-072, Portugal
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Institut Gustave Roussy
RECRUITINGVillejuif, 94805, France
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Instituto Medico Especializado Alexander Fleming
RECRUITINGCiudad Autónoma de Bs As, C1426ANZ, Argentina
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Instituto Nacional de Cancerologia
RECRUITINGMéxico, 14080, Mexico
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Istituti Fisioterapici Ospitalieri
RECRUITINGRoma, 00144, Italy
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Istituto Clinico Humanitas
RECRUITINGRozzano (MI), 20089, Italy
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Istituto Nazionale IRCCS Tumori Fondazione Pascale
RECRUITINGNaples, 80131, Italy
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Istituto Tumori Giovanni Paolo II
RECRUITINGBari, 70124, Italy
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Japanese Foundation for Cancer Research
RECRUITINGTokyo, Koto-ku, 135-8550, Japan
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Jichi Medical University Hospital
RECRUITINGTochigi, Shimotsuke, 329-0498, Japan
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Juntendo University Hospital
RECRUITINGTokyo, Bunkyo-ku, 113-8431, Japan
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Kanagawa Cancer Center
RECRUITINGKanagawa, Yokohama, 241-8515, Japan
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Kansai Medical University Hospital
RECRUITINGOsaka, Hirakata, 573-1191, Japan
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Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITINGKaohsiung City, 807, Taiwan
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Karolinska Universitetssjukhuset Solna
RECRUITINGStockholm, 171 76, Sweden
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Kindai University Hospital
RECRUITINGOsaka, Sakai, 590-0197, Japan
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Kitasato University Hospital
RECRUITINGKanagawa, Sagamihara, 252-0375, Japan
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Klinikum Esslingen
RECRUITINGEsslingen am Neckar, 73730, Germany
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Kyushu University Hospital
RECRUITINGFukuoka, Fukuoka, 812-8582, Japan
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Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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Levine Cancer Institute
NOT_YET_RECRUITINGCharlotte, North Carolina, 28204, United States
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Linyi Cancer Hospital
RECRUITINGLinyi, 276034, China
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Lotus Med
RECRUITINGBucharest, 012292, Romania
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LungenClinic Grosshansdorf GmbH
RECRUITINGGroßhansdorf, 22927, Germany
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Medeniyet University
NOT_YET_RECRUITINGIstanbul, 34862, Turkey (Türkiye)
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Medical Park Seyhan Hastanesi
RECRUITINGAdana, Turkey (Türkiye)
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Medical University of Innsbruck
NOT_YET_RECRUITINGInnsbruck, A-6020, Austria
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Meir Medical Center
NOT_YET_RECRUITINGKfar Saba, 44281, Israel
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Memorial Healthcare International
RECRUITINGBucharest, 013823, Romania
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Memorial Sloan-Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
-
Mid Florida Hematology and Oncology Center
RECRUITINGOrange City, Florida, 32763, United States
-
Nanjing Drum Tower Hospital
RECRUITINGNanjing, 210008, China
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National Cancer Center
RECRUITINGGoyang, 10408, South Korea
-
National Cancer Center Hospital
RECRUITINGTokyo, Chuo-ku, 104-0045, Japan
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National Cancer Center Hospital East
NOT_YET_RECRUITINGChiba, Kashiwa, 277-8577, Japan
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National Cancer Centre Singapore
RECRUITINGSingapore, 168583, Singapore
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National Hospital Organization Kinki-Chuo Chest Medical Center
RECRUITINGOsaka, Sakai, 591-8555, Japan
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National Taiwan University Hospital
RECRUITINGTaipei, 10048, Taiwan
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Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
RECRUITINGAmsterdam, 1066CX, Netherlands
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NewData Clinical Research - Maceió
RECRUITINGMaceió, 57020-360, Brazil
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Niigata Cancer Center Hospital
RECRUITINGNiigata, Niigata, 951-8566, Japan
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Ningbo Second Hospital
RECRUITINGNingbo, 315010, China
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Northern California Kaiser Permanente
NOT_YET_RECRUITINGVallejo, California, 94589, United States
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Northern Jiangsu People's Hospital
RECRUITINGYangzhou, 225001, China
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Northwest Georgia Oncology Centers
RECRUITINGMarietta, Georgia, 30060, United States
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Northwestern University
NOT_YET_RECRUITINGChicago, Illinois, 60611, United States
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OPN Healthcare, Inc.
RECRUITINGGlendale, California, 91203, United States
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Okayama University Hospital
RECRUITINGOkayama, Okayama, 700-8558, Japan
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Osaka International Cancer Institute
RECRUITINGOsaka, Osaka, 541-8567, Japan
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Ovidius Clinical Hospital S.R.L
RECRUITINGOvidiu, 905900, Romania
-
Piedmont Cancer Institute
RECRUITINGAtlanta, Georgia, 30318, United States
-
Pius-Hospital, Oldenburg
RECRUITINGOldenburg, 26121, Germany
-
Polaris Medical S.A.
NOT_YET_RECRUITINGSuceagu/ Cluj Napoca, 407062, Romania
-
Prince of Wales Hospital-Hong Kong-20715
RECRUITINGHong Kong, 999077, Hong Kong
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Princess Alexandra Hospital
NOT_YET_RECRUITINGWoolloongabba, 4102, Australia
-
Princess Margaret Cancer Centre
NOT_YET_RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Princess Margaret Hospital
RECRUITINGHong Kong, 999077, Hong Kong
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Providence Cancer Institute
RECRUITINGPortland, Oregon, 97213, United States
-
Queen Elizabeth Hospital-Hong Kong-51727
RECRUITINGHong Kong, 51727, Hong Kong
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Queen Mary Hospital
RECRUITINGHong Kong, Hong Kong
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Rambam Health Care Campus
NOT_YET_RECRUITINGHaifa, 3109601, Israel
-
Royal North Shore Hospital
RECRUITINGSydney, 2065, Australia
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Sahlgrenska Universitetsjukhuset
RECRUITINGGothenburg, 413 46, Sweden
-
Saint Alphonsus Regional Medical Center - Boise
NOT_YET_RECRUITINGBoise, Idaho, 83706, United States
-
Saitama Cancer Center
RECRUITINGSaitama, Kitaadachi-gun, 362-0806, Japan
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Saitama Medical University International Medical Center
RECRUITINGSaitama, Hidaka, 350-1298, Japan
-
Salut Sant Joan de Reus
RECRUITINGReus, 43204, Spain
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
-
Sarcoma Oncology Center
RECRUITINGSanta Monica, California, 90403, United States
-
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
RECRUITINGAnkara, 06018, Turkey (Türkiye)
-
Sendai Kousei Hospital
RECRUITINGMiyagi, Sendai, 981-0914, Japan
-
Seoul National University Bundang Hospital
RECRUITINGSeongnam, 13620, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
-
Severance Hospital
RECRUITINGSeoul, 03722, South Korea
-
Shaare Zedek Medical Center
NOT_YET_RECRUITINGJerusalem, 9103102, Israel
-
Shandong Cancer Hospital
RECRUITINGJinan, 250117, China
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Shanghai East Hospital
RECRUITINGShanghai, 200121, China
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Shanghai Pulmonary Hospital
RECRUITINGShanghai, 200433, China
-
Sheba Medical Center
NOT_YET_RECRUITINGRamat Gan, 5262000, Israel
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Shizuoka Cancer Center
RECRUITINGShizuoka, Sunto-gun, 411-8777, Japan
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Sichuan Cancer Hospital
RECRUITINGChengdu, 610041, China
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Sjællands Universitetshospital
NOT_YET_RECRUITINGRoskilde, 4000, Denmark
-
Sourasky Medical Center
NOT_YET_RECRUITINGTel Aviv, 6093246, Israel
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St John of God Subiaco Hospital
RECRUITINGSubiaco, Western Australia, 6008, Australia
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Sutter Health
NOT_YET_RECRUITINGRoseville, California, 95661, United States
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Taipei Veterans General Hospital
RECRUITINGTaipei, 11217, Taiwan
-
Taizhou Hospital of Zhejiang Province
RECRUITINGTaizhou, 317099, China
-
The Affiliated Hospital of Xuzhou Medical College
RECRUITINGXuzhou, 221009, China
-
The Catholic University of Korea, St.Vincent's Hospital
RECRUITINGSuwon, 16247, South Korea
-
The Christie Hospital
RECRUITINGManchester, M20 4BX, United Kingdom
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The First Affiliated Hospital of Nanchang University
RECRUITINGNanchang, 330006, China
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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, 215006, China
-
The First Affiliated Hospital, Zhejiang University
RECRUITINGHangzhou, 310003, China
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The First Affiliated Hospital,Sun Yat-sen University
RECRUITINGGuangzhou, 510080, China
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The First Hospital of Jilin University
RECRUITINGChangchun, 130000, China
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The Royal Marsden Hospital, Chelsea
RECRUITINGLondon, SW3 6JJ, United Kingdom
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The Royal Marsden Hospital, Sutton
RECRUITINGSutton, SM2 5PT, United Kingdom
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The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
RECRUITINGHeidelberg, 69126, Germany
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Tianjin Cancer Hospital
RECRUITINGTianjin, 300060, China
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Tianjin Medical University General Hospital
RECRUITINGTianjin, 30052, China
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Tokyo Medical University Hospital
RECRUITINGTokyo, Shinjuku-ku, 160-0023, Japan
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Tri-Service General Hospital
RECRUITINGTaipei, 114, Taiwan
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITINGWuhan, 430056, China
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Universitair Ziekenhuis Antwerpen
RECRUITINGEdegem, 2650, Belgium
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University General Hospital Attikon
NOT_YET_RECRUITINGAthens, 12462, Greece
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University of California Irvine
RECRUITINGOrange, California, 92868, United States
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University of California Los Angeles
RECRUITINGSanta Monica, California, 90404, United States
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University of California San Francisco
RECRUITINGSan Francisco, California, 94158, United States
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University of Illinois Hospital and Health Sciences System
RECRUITINGChicago, Illinois, 60612, United States
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Universitätsklinikum Köln (AöR)
RECRUITINGCologne, 50937, Germany
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Universitätsklinikum Würzburg AÖR
RECRUITINGWürzburg, 97078, Germany
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Varisano LungenZentrum (VLZ)
RECRUITINGFrankfurt, 65929, Germany
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Velindre Cancer Centre
NOT_YET_RECRUITINGCardiff, CF14 2TL, United Kingdom
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Virginia Cancer Specialists, PC
RECRUITINGFairfax, Virginia, 22031, United States
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Wakayama Medical University Hospital
RECRUITINGWakayama, Wakayama, 641-8510, Japan
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West China Hospital, Sichuan University
RECRUITINGChengdu, 610041, China
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Western General Hospital
RECRUITINGEdinburgh, EH4 2XU, United Kingdom
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Xiangya Hospital, Central South University
NOT_YET_RECRUITINGChangsha, 410008, China
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Yunnan Provincial Tumor Hospital
RECRUITINGKunming, 650118, China
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, 310022, China
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