Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD... | NCT07195695 | Trialant

Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD... | NCT07195695 | Trialant

Official Title: Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations
Brief Summary: Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.

Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.
Detailed Description: This is a global, randomized, open-label, Phase 3 study designed to assess the efficacy and safety of zongertinib as adjuvant therapy in participants with completely resected Stage II-IIIB NSCLC and HER2 TKD-activating mutations.

Participants must have undergone complete resection and received perioperative systemic therapy consistent with current standards, including either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.

After completing surgery and required systemic treatment, eligible participants are randomized 1:1 to receive either Zongertinib taken orally once daily for up to 3 years, or standard treatment, which may include an approved adjuvant immunotherapy agent administered according to its label, or observation, depending on local clinical practice and patient status.

The primary objective is to evaluate whether zongertinib improves disease-free survival (DFS) compared with standard treatment. Secondary objectives include overall survival (OS), safety, tolerability, and patient-reported outcomes.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion criteria:

Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Patients must be ≥18 years old or over the legal age of consent in their country

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

HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations

Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC

An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status

Staging: Pretherapeutic classification not exceeding Stage IIIB

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:

Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)

Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization

Treatment with radiation therapy for primary NSCLC

Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))

Any investigational drug within 5 half-lives of the compound or any of its related material, if known

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.

ClinRé 001-022 (Premier Cancer Care and Infusion Center)Recruiting

Fresno, California 93710, United States

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OPN Healthcare, Inc.Recruiting

Glendale, California 91203, United States

University of California IrvineNot yet recruiting

Orange, California 92868, United States

Sutter HealthNot yet recruiting

Roseville, California 95661, United States

University of California San FranciscoRecruiting

San Francisco, California 94158, United States

Sarcoma Oncology CenterRecruiting

Santa Monica, California 90403, United States

University of California Los AngelesRecruiting

Santa Monica, California 90404, United States

Northern California Kaiser PermanenteNot yet recruiting

Vallejo, California 94589, United States

George Washington University Cancer CenterNot yet recruiting

Washington D.C., District of Columbia 20037, United States

Mid Florida Hematology and Oncology CenterRecruiting

Orange City, Florida 32763, United States

Piedmont Cancer InstituteRecruiting

Atlanta, Georgia 30318, United States

Northwest Georgia Oncology CentersRecruiting

Marietta, Georgia 30060, United States

Saint Alphonsus Regional Medical Center - BoiseNot yet recruiting

Boise, Idaho 83706, United States

Northwestern UniversityNot yet recruiting

Chicago, Illinois 60611, United States

University of Illinois Hospital and Health Sciences SystemRecruiting

Chicago, Illinois 60612, United States

Duly Health and Care - LisleRecruiting

Lisle, Illinois 60532, United States

Dana-Farber Cancer InstituteRecruiting

Boston, Massachusetts 02215, United States

Cancer Care SpecialistsRecruiting

Reno, Nevada 89511, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting

New York, New York 10016, United States

Memorial Sloan-Kettering Cancer CenterRecruiting

New York, New York 10065, United States

Levine Cancer InstituteNot yet recruiting

Charlotte, North Carolina 28204, United States

Durham VA Health Care SystemNot yet recruiting

Durham, North Carolina 27705, United States

Providence Cancer InstituteRecruiting

Portland, Oregon 97213, United States

Hendrick HealthRecruiting

Abilene, Texas 79601, United States

The University of Texas MD Anderson Cancer CenterNot yet recruiting

Houston, Texas 77030, United States

Community Cancer Trials of UtahRecruiting

Ogden, Utah 84405, United States

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Fairfax, Virginia 22031, United States

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CABA, 1185, Argentina

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CABA, 1280AEB, Argentina

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CABA, 1426, Argentina

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CABA, 1430, Argentina

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Ciudad Autónoma de Bs As, C1426ANZ, Argentina

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Flinders Medical CentreNot yet recruiting

Bedford Park, South Australia 5042, Australia

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Subiaco, Western Australia 6008, Australia

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Heidelberg, 3084, Australia

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Sydney, 2065, Australia

Princess Alexandra HospitalNot yet recruiting

Woolloongabba, 4102, Australia

Medical University of InnsbruckNot yet recruiting

Innsbruck, A-6020, Austria

Clinic FloridsdorfRecruiting

Vienna, 1210, Austria

Universitair Ziekenhuis AntwerpenRecruiting

Edegem, 2650, Belgium

UZ LeuvenRecruiting

Leuven, 3000, Belgium

Centre Hospitalier Universitaire de LiègeNot yet recruiting

Liège, 4000, Belgium

Hospital de AmorRecruiting

Barretos, 14784-400, Brazil

NewData Clinical Research - MaceióRecruiting

Maceió, 57020-360, Brazil

Centro de Pesquisa Oncology NatalRecruiting

Natal, 59020-400, Brazil

Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e PesquisaRecruiting

Porto Alegre, 90110-270, Brazil

CEPHO - Centro de Estudos e Pesquisas em Hematologia e OncologiaRecruiting

Santo André, 09060-650, Brazil

ICESP - Instituto do Cancer do Estado de Sao PauloNot yet recruiting

São Paulo, 01246-000, Brazil

A.C. CamargoRecruiting

São Paulo, 01509-010, Brazil

Cross Cancer Institute (University of Alberta)Not yet recruiting

Edmonton, Alberta T6G 1Z2, Canada

Princess Margaret Cancer CentreNot yet recruiting

Toronto, Ontario M5G 2M9, Canada

Centro de Estudios Clinicos SAGARecruiting

Providencia, 7500653, Chile

Bradford Hill- Centro de Investigacion ClinicaRecruiting

Recoleta, 8420383, Chile

China-Japan Friendship HospitalRecruiting

Beijing, 100029, China

Beijing Chest Hospital, Capital Medical UniversityRecruiting

Beijing, 101149, China

The First Hospital of Jilin UniversityRecruiting

Changchun, 130000, China

Xiangya Hospital, Central South UniversityNot yet recruiting

Changsha, 410008, China

Hunan Province Tumor HospitalNot yet recruiting

Changsha, 410013, China

Sichuan Cancer HospitalRecruiting

Chengdu, 610041, China

West China Hospital, Sichuan UniversityRecruiting

Chengdu, 610041, China

The First Affiliated Hospital,Sun Yat-sen UniversityRecruiting

Guangzhou, 510080, China

The First Affiliated Hospital, Zhejiang UniversityRecruiting

Hangzhou, 310003, China

Zhejiang Cancer HospitalRecruiting

Hangzhou, 310022, China

Harbin Medical University Cancer HospitalRecruiting

Harbin, 150081, China

Shandong Cancer HospitalRecruiting

Jinan, 250117, China

Yunnan Provincial Tumor HospitalRecruiting

Kunming, 650118, China

Linyi Cancer HospitalRecruiting

Linyi, 276034, China

The First Affiliated Hospital of Nanchang UniversityRecruiting

Nanchang, 330006, China

Nanjing Drum Tower HospitalRecruiting

Nanjing, 210008, China

Ningbo Second HospitalRecruiting

Ningbo, 315010, China

Shanghai East HospitalRecruiting

Shanghai, 200121, China

Shanghai Pulmonary HospitalRecruiting

Shanghai, 200433, China

Hebei Provincial Tumor HospitalNot yet recruiting

Shijiazhuang, 050035, China

The First Affiliated Hospital of Soochow UniversityRecruiting

Suzhou, 215006, China

Taizhou Hospital of Zhejiang ProvinceRecruiting

Taizhou, 317099, China

Tianjin Cancer HospitalRecruiting

Tianjin, 300060, China

Tianjin Medical University General HospitalRecruiting

Tianjin, 30052, China

Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting

Wuhan, 430056, China

The Affiliated Hospital of Xuzhou Medical CollegeRecruiting

Xuzhou, 221009, China

Northern Jiangsu People's HospitalRecruiting

Yangzhou, 225001, China

Henan Cancer HospitalNot yet recruiting

Zhengzhou, 450008, China

Sjællands UniversitetshospitalNot yet recruiting

Roskilde, 4000, Denmark

Hôpital Louis PradelRecruiting

Bron, 69677, France

HOP NordRecruiting

Marseille, 13915, France

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Nantes, 44093, France

HOP Tenon - One AP-HPRecruiting

Paris, 75970, France

HOP PontchaillouRecruiting

Rennes, 35033, France

Centre Régional de Lutte Contre le Cancer Paul StaussRecruiting

Strasbourg, 67200, France

Hôpital Larrey - CHU de ToulouseRecruiting

Toulouse, 31059, France

Institut Gustave RoussyRecruiting

Villejuif, 94805, France

Charité - Universitätsmedizin BerlinNot yet recruiting

Berlin, 12203, Germany

Universitätsklinikum Köln (AöR)Recruiting

Cologne, 50937, Germany

Klinikum EsslingenRecruiting

Esslingen am Neckar, 73730, Germany

Varisano LungenZentrum (VLZ)Recruiting

Frankfurt, 65929, Germany

Asklepios Fachkliniken München-GautingNot yet recruiting

Gauting, 82131, Germany

LungenClinic Grosshansdorf GmbHRecruiting

Großhansdorf, 22927, Germany

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum HeidelbergRecruiting

Heidelberg, 69126, Germany

Pius-Hospital, OldenburgRecruiting

Oldenburg, 26121, Germany

Universitätsklinikum Würzburg AÖRRecruiting

Würzburg, 97078, Germany

Henry Dunant Hospital, AthensNot yet recruiting

Athens, 11526, Greece

Chest Hospital of Athens "Sotiria"Not yet recruiting

Athens, 11527, Greece

University General Hospital AttikonNot yet recruiting

Athens, 12462, Greece

Queen Elizabeth Hospital-Hong Kong-51727Recruiting

Hong Kong, 51727, Hong Kong

Prince of Wales Hospital-Hong Kong-20715Recruiting

Hong Kong, 999077, Hong Kong

Princess Margaret HospitalRecruiting

Hong Kong, 999077, Hong Kong

Queen Mary HospitalRecruiting

Hong Kong, Hong Kong

Rambam Health Care CampusNot yet recruiting

Haifa, 3109601, Israel

Shaare Zedek Medical CenterNot yet recruiting

Jerusalem, 9103102, Israel

Meir Medical CenterNot yet recruiting

Kfar Saba, 44281, Israel

Sheba Medical CenterNot yet recruiting

Ramat Gan, 5262000, Israel

Sourasky Medical CenterNot yet recruiting

Tel Aviv, 6093246, Israel

Istituto Tumori Giovanni Paolo IIRecruiting

Bari, 70124, Italy

Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting

Milan, 20133, Italy

Humanitas Istituto Clinico Catanese S.p.A.Recruiting

Misterbianco (CT), 95045, Italy

Istituto Nazionale IRCCS Tumori Fondazione PascaleRecruiting

Naples, 80131, Italy

AOU San Luigi GonzagaRecruiting

Orbassano (TO), 10043, Italy

Istituti Fisioterapici OspitalieriRecruiting

Roma, 00144, Italy

Istituto Clinico HumanitasRecruiting

Rozzano (MI), 20089, Italy

Azienda Ospedaliera Universitaria Integrata VeronaRecruiting

Verona, 37126, Italy

Aichi Cancer Center HospitalRecruiting

Aichi, Nagoya, 464-8681, Japan

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Fujita Health University HospitalRecruiting

Aichi, Toyoake, 470-1192, Japan

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National Cancer Center Hospital EastNot yet recruiting

Chiba, Kashiwa, 277-8577, Japan

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Kyushu University HospitalRecruiting

Fukuoka, Fukuoka, 812-8582, Japan

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Hospital of the University of Occupational and Environmental HealthRecruiting

Fukuoka, Kitakyushu, 807-8556, Japan

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Hiroshima, Hiroshima, 734-8551, Japan

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Hokkaido Cancer CenterRecruiting

Hokkaido, Sapporo, 003-0804, Japan

Kitasato University HospitalRecruiting

Kanagawa, Sagamihara, 252-0375, Japan

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Kanagawa Cancer CenterRecruiting

Kanagawa, Yokohama, 241-8515, Japan

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Sendai Kousei HospitalRecruiting

Miyagi, Sendai, 981-0914, Japan

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Niigata Cancer Center HospitalRecruiting

Niigata, Niigata, 951-8566, Japan

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Okayama University HospitalRecruiting

Okayama, Okayama, 700-8558, Japan

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Kansai Medical University HospitalRecruiting

Osaka, Hirakata, 573-1191, Japan

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Osaka International Cancer InstituteRecruiting

Osaka, Osaka, 541-8567, Japan

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Kindai University HospitalRecruiting

Osaka, Sakai, 590-0197, Japan

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National Hospital Organization Kinki-Chuo Chest Medical CenterRecruiting

Osaka, Sakai, 591-8555, Japan

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Saitama Medical University International Medical CenterRecruiting

Saitama, Hidaka, 350-1298, Japan

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Saitama Cancer CenterRecruiting

Saitama, Kitaadachi-gun, 362-0806, Japan

Shizuoka Cancer CenterRecruiting

Shizuoka, Sunto-gun, 411-8777, Japan

Jichi Medical University HospitalRecruiting

Tochigi, Shimotsuke, 329-0498, Japan

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Juntendo University HospitalRecruiting

Tokyo, Bunkyo-ku, 113-8431, Japan

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National Cancer Center HospitalRecruiting

Tokyo, Chuo-ku, 104-0045, Japan

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Japanese Foundation for Cancer ResearchRecruiting

Tokyo, Koto-ku, 135-8550, Japan

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Tokyo Medical University HospitalRecruiting

Tokyo, Shinjuku-ku, 160-0023, Japan

Wakayama Medical University HospitalRecruiting

Wakayama, Wakayama, 641-8510, Japan

Boehringer IngelheimContact

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Centro Oncologico InternacionalNot yet recruiting

Jalisco, 45640, Mexico

Centro de Infusion Profesional Integral (CIPI)Recruiting

Mexico City, 14210, Mexico

Centro Oncologico PersonalizadoNot yet recruiting

México, 06760, Mexico

Instituto Nacional de CancerologiaRecruiting

México, 14080, Mexico

Centro Medico Zambrano HellionNot yet recruiting

Monterrey, 66278, Mexico

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)Recruiting

Amsterdam, 1066CX, Netherlands

Hospital CUF TejoRecruiting

Lisbon, 1350-352, Portugal

Hospital da LuzRecruiting

Lisbon, 1500-650, Portugal

Hospital CUF PortoRecruiting

Porto, 4100-180, Portugal

IPO Porto Francisco Gentil, EPENot yet recruiting

Porto, 4200-072, Portugal

Lotus MedRecruiting

Bucharest, 012292, Romania

Memorial Healthcare InternationalRecruiting

Bucharest, 013823, Romania

Ovidius Clinical Hospital S.R.LRecruiting

Ovidiu, 905900, Romania

Polaris Medical S.A.Not yet recruiting

Suceagu/ Cluj Napoca, 407062, Romania

Boehringer IngelheimContact

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National Cancer Centre SingaporeRecruiting

Singapore, 168583, Singapore

National Cancer CenterRecruiting

Goyang, 10408, South Korea

Seoul National University Bundang HospitalRecruiting

Seongnam, 13620, South Korea

Seoul National University HospitalRecruiting

Seoul, 03080, South Korea

Severance HospitalRecruiting

Seoul, 03722, South Korea

Asan Medical CenterRecruiting

Seoul, 05505, South Korea

Samsung Medical CenterRecruiting

Seoul, 06351, South Korea

The Catholic University of Korea, St.Vincent's HospitalRecruiting

Suwon, 16247, South Korea

Ajou University HospitalRecruiting

Suwon, 16499, South Korea

Hospital del MarRecruiting

Barcelona, 08003, Spain

Hospital Universitari Vall d'HebronRecruiting

Barcelona, 08035, Spain

Hospital Universitario De BurgosRecruiting

Burgos, 09006, Spain

Hospital General Universitario de ElcheNot yet recruiting

Elche, 03203, Spain

Hospital Jerez de la FronteraRecruiting

Jerez de la Frontera, 11407, Spain

Hospital Universitario Ramon Y CajalRecruiting

Madrid, 28034, Spain

Fundación Jiménez DíazRecruiting

Madrid, 28040, Spain

Hospital Universitario 12 de OctubreRecruiting

Madrid, 28041, Spain

Hospital Puerta de HierroRecruiting

Majadahonda, 28222, Spain

Hospital Universitario Virgen de la VictoriaRecruiting

Málaga, 29010, Spain

Complejo Hospitalario de NavarraRecruiting

Pamplona, 31008, Spain

Salut Sant Joan de ReusRecruiting

Reus, 43204, Spain

Hospital Virgen del RocíoRecruiting

Seville, 41013, Spain

Hospital Clinico Universitario de ValenciaRecruiting

Valencia, 46010, Spain

Sahlgrenska UniversitetsjukhusetRecruiting

Gothenburg, 413 46, Sweden

Karolinska Universitetssjukhuset SolnaRecruiting

Stockholm, 171 76, Sweden

Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting

Kaohsiung City, 807, Taiwan

China Medical University HospitalRecruiting

Taichung, 40447, Taiwan

National Taiwan University HospitalRecruiting

Taipei, 10048, Taiwan

Taipei Veterans General HospitalRecruiting

Taipei, 11217, Taiwan

Tri-Service General HospitalRecruiting

Taipei, 114, Taiwan

Chang Gung Memorial Hospital, LinkouRecruiting

Taoyuan City, 333, Taiwan

Adana Şehir HastanesiRecruiting

Adana, Turkey (Türkiye)

Medical Park Seyhan HastanesiRecruiting

Adana, Turkey (Türkiye)

Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma HastanesiRecruiting

Ankara, 06018, Turkey (Türkiye)

Ankara University Medical Faculty HospitalRecruiting

Ankara, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma HastanesiRecruiting

Ankara, Turkey (Türkiye)

Medeniyet UniversityNot yet recruiting

Istanbul, 34862, Turkey (Türkiye)

Ankara Bilkent Sehir HastanesiNot yet recruiting

Türkiye, Turkey (Türkiye)

Boehringer IngelheimContact

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Velindre Cancer CentreNot yet recruiting

Cardiff, CF14 2TL, United Kingdom

Western General HospitalRecruiting

Edinburgh, EH4 2XU, United Kingdom

Guy's HospitalRecruiting

London, SE1 9RT, United Kingdom

The Royal Marsden Hospital, ChelseaRecruiting

London, SW3 6JJ, United Kingdom

The Christie HospitalRecruiting

Manchester, M20 4BX, United Kingdom

The Royal Marsden Hospital, SuttonRecruiting

Sutton, SM2 5PT, United Kingdom