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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506235-15 | Other Identifier | EU CT Number |
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The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tarlatamab | Experimental | Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days). |
|
| Placebo | Placebo Comparator | Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarlatamab | Drug | Intravenous (IV) infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS as Determined by BICR | Up to approximately 6 years | |
| OS Over the Whole Trial | Up to approximately 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Determined by Investigator Assessment | Up to approximately 6 years | |
| Complete Response (CR) Rate | Up to approximately 6 years | |
| CR + non-CR/non-Progressive Disease (PD) Rate |
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Inclusion Criteria: -Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria: -Participants are excluded from the study if any of the following criteria apply:
Disease Related
Prior/Concomitant Therapy
Prior/Concurrent Clinical Study Experience
• Treatment in an alternative investigational trial within 28 days prior to enrollment.
Other Exclusions
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | United States | ||
| University of California Los Angeles |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| Placebo | Drug | IV infusion |
|
| Up to approximately 6 years |
| Duration of Complete Response | Up to approximately 6 years |
| PFS at 6 months, 1 year, 2 years | 6 months, 1 year, 2 years |
| OS at 6 months, 1 year, 2 years, 3 years | 6 months, 1 year, 2 years, 3 years |
| Time to Progression (TTP) | Up to approximately 6 years |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to approximately 6 years |
| Serum Concentration of Tarlatamab | Up to approximately 4 months |
| Incidence of Anti-tarlatamab Antibody Formation | Up to approximately 1 year |
| Santa Monica |
| California |
| 90404 |
| United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Boca Raton Clinical Research Global South Florida | Plantation | Florida | 33322 | United States |
| University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Our Lady of the Lake Cancer Institute | Baton Rouge | Louisiana | 70808 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| New York University Grossman School of Medicine and New York University Langone Hospitals | New York | New York | 10016 | United States |
| Perlmutter Cancer Center at New York University Langone Hospital - Long Island | New York | New York | 10016 | United States |
| Montefiore Einstein Center for Cancer Care | The Bronx | New York | 10461 | United States |
| FirstHealth Cancer Center | Pinehurst | North Carolina | 28374 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Spokenword Clinical Trials | Easton | Pennsylvania | 18045 | United States |
| Renovatio Clinical | The Woodlands | Texas | 77380 | United States |
| US Oncology Research Investigational Products Center | The Woodlands | Texas | 77380 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| West Virginia University Health Sciences Center | Morgantown | West Virginia | 26506 | United States |
| Fundacion Respirar | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| Hospital Italiano de La Plata | La Plata | Buenos Aires | 1900 | Argentina |
| Hospital Universitario Austral | Pilar | Buenos Aires | B1629ODT | Argentina |
| Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo | Córdoba | Córdoba Province | 5003 | Argentina |
| Hospital Aleman Buenos Aires | CABA | Distrito Federal | C1118AAT | Argentina |
| Clinica Viedma | Viedma | Río Negro Province | R8500ACE | Argentina |
| Sanatorio 9 de Julio Cice 9 de Julio | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Instituto Argentino de Diagnóstico y Tratamiento | Buenos Aires | C1122AAL | Argentina |
| Port Macquarie Base Hospital | Port Macquarie | New South Wales | 2444 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Medizinische Universitaet Graz | Graz | 8036 | Austria |
| Universitaetsklinikum Allgemeines Krankenhaus Wien | Vienna | 1090 | Austria |
| Institut Jules Bordet | Brussels | B-1070 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Hospital Santa Rita | Vitória | Espírito Santo | 29043-260 | Brazil |
| Oncoclinicas Onco Vida Distrito Federal | Brasília | Federal District | 70200-730 | Brazil |
| Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner | Curitba | Paraná | 81520-060 | Brazil |
| Londrina Cancer Hospital | Londrina | Paraná | 86015-520 | Brazil |
| Liga Norte-Riograndense Contra O Cancer | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Cipo - Centro Integrado de Pesquisa em Oncologia | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Centro de pesquisa em oncologia Hospital Ana Nery | Santa Cruz do Sul | Rio Grande do Sul | 96835-090 | Brazil |
| Centro Catarinense de Pesquisa LTDA | Blumenau | Santa Catarina | 89015-200 | Brazil |
| Fundacao pio xII Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Fundacao Amaral Carvalho | Jaú | São Paulo | 17210-120 | Brazil |
| Cepho | Santo André | São Paulo | 09060-650 | Brazil |
| Instituto Dor de Pesquisa e Ensino | Rio de Janeiro | 22793-080 | Brazil |
| Instituto Cancer Sao Paulo Icesp | São Paulo | 01246-000 | Brazil |
| Multiprofile Hospital for Active Treatment - Uni Hospital OOD | Panagyurishte | 4500 | Bulgaria |
| Complex Oncology Center Plovdiv EOOD | Plovdiv | 4004 | Bulgaria |
| Complex Oncology Center Shumen EOOD | Shumen | 9700 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sofiamed OOD | Sofia | 1113 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD | Sofia | 1527 | Bulgaria |
| Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia | Sofia | 1606 | Bulgaria |
| Multiprofile Hospital for Active Treatment Serdikamed EOOD | Sofia | 1632 | Bulgaria |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | 350025 | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430070 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Northern Jiangsu Peoples hospital | Yangzhou | Jiangsu | 225009 | China |
| Jiangxi Cancer hospital | Nanchang | Jiangxi | 330029 | China |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Cancer Hospital of Shandong First Medical University | Jinan | Shandong | 250117 | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | 266000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | 030009 | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | 030032 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830011 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Ningbo Medical Center Lihuili Hospital | Ningbo | Zhejiang | 315016 | China |
| Zhejiang Taizhou Hospital | Taizhou | Zhejiang | 317099 | China |
| Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic | Bogota | Cundinamarca | 0129 | Colombia |
| Instituto Nacional de Cancerologia | Bogota | Cundinamarca | 111711 | Colombia |
| Instituto Medico de Alta Tecnologia sas - Imat sas | Montería | Departamento de Córdoba | Colombia |
| Oncologos del Occidente SAS | Pereira | Risaralda Department | 660001 | Colombia |
| Fundacion cardiovascular de Colombia | Bucaramanga | Santander Department | 681017 | Colombia |
| Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon | Lille | 59037 | France |
| Centre Hospitalier Universitaire Nord | Marseille | 13915 | France |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur | Nice | 06002 | France |
| Hopital Bichat Claude Bernard | Paris | 75018 | France |
| Hopital Nord Ouest Villefranche sur Saone | Villefranche-sur-Saône | 69400 | France |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Universitaetsmedizin Goettingen | Göttingen | 37075 | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | 97078 | Germany |
| Agios Savvas Anticancer Hospital | Athens | 11522 | Greece |
| Henry Dunant Hospital Center | Athens | 11526 | Greece |
| Sotiria General Hospital | Athens | 11527 | Greece |
| University General Hospital Attikon General Hospital Of West Attica H Agia Varvara | Athens | 12462 | Greece |
| Metropolitan General | Athens | 15562 | Greece |
| Metropolitan Hospital | Athens | 18547 | Greece |
| Saint Luke Hospital | Thessaloniki | 55236 | Greece |
| European Interbalkan Medical Center | Thessaloniki | 57001 | Greece |
| Queen Mary Hospital, The University of Hong Kong | Hong Kong | Hong Kong |
| Prince of Wales Hospital, Chinese University of Hong Kong | Shatin, New Territories | Hong Kong |
| Centro di Riferimento Oncologico di Aviano | Aviano PN | 33081 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| IRCCS Istituto Oncologico Europeo | Milan | 20141 | Italy |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga | Orbassano | 10043 | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia | Perugia | 06156 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56124 | Italy |
| Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova | Reggio Emilia | 42123 | Italy |
| IRCCS Istituto Clinico Humanitas | Rozzano MI | 20089 | Italy |
| Ospedale San Giuseppe Moscati | Statte | 74010 | Italy |
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Kurume University Hospital | Kurume-shi | Fukuoka | 830-0011 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Sendai Kousei Hospital | Sendai | Miyagi | 981-0914 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Kansai Medical University Hospital | Hirakata-shi | Osaka | 573-1191 | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | 541-8567 | Japan |
| Kindai University Hospital | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Saitama Medical University International Medical Center | Hidaka-Shi | Saitama | 350-1298 | Japan |
| Saitama Cancer Center | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641-8509 | Japan |
| Centro Oncologico Personalizado | Cuauhtémoc | Mexico City | 06760 | Mexico |
| Oncare | Mexico City | Mexico City | 03810 | Mexico |
| Oncocenter Clinica Integral Internacional de Oncologia | Puebla City | 72530 | Mexico |
| Phylasis Clinicas Research Toluca | Toluca | 50090 | Mexico |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | 15-540 | Poland |
| Centrum Pulmonologii i Torakochirurgii w Bystrej | Bystra | 43-360 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie | Lublin | 20-090 | Poland |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow | Poznan | 60-569 | Poland |
| Szpital Specjalistyczny w Prabutach Spolka z Ograniczoną Odpowiedzialnoscia | Prabuty | 82-550 | Poland |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu | Przemyśl | 37-700 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Unidade Local de Saude de Braga, EPE | Braga | 4710-243 | Portugal |
| Hospital da Luz, SA | Lisbon | 1500-650 | Portugal |
| Hospital Cuf porto | Porto | 4100-180 | Portugal |
| Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu | Balotesti, Ilfov | 077015 | Romania |
| Institutul Oncologic, Prof Dr Alexandru Trestioreanu | Bucharest | 022328 | Romania |
| Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Centrul de Oncologie Sf Nectarie SRL | Craiova | 200542 | Romania |
| Institutul Regional de Oncologie Iasi | Iași | 700483 | Romania |
| Spitalul Municipal Ploiesti | Ploieşti | 100337 | Romania |
| SC Oncomed SRL | Timișoara | 300239 | Romania |
| National Cancer Centre Singapore | Singapore | 168583 | Singapore |
| Icon - Mount Alvernia | Singapore | 217562 | Singapore |
| Chungbuk National University Hospital | Cheongju Chungbuk | 28644 | South Korea |
| National Cancer Center | Goyang-si Gyeonggi-do | 10408 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Gyeongsang National University Hospital | Jinju | 52727 | South Korea |
| Cha Bundang Medical Center, Cha University | Seongnam-si, Gyeonggi-do | 13496 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | 13620 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Hospital Regional Universitario de Malaga | Málaga | Andalusia | 29011 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Aragon | 50009 | Spain |
| Hospital Universitario Insular de Gran Canaria | Las Palmas de Gran Canaria | Canary Islands | 35016 | Spain |
| Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol | Badalona | Catalonia | 08916 | Spain |
| Hospital del Mar | Barcelona | Catalonia | 08003 | Spain |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08041 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | Galicia | 15706 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Instituto Valenciano de Oncologia | Valencia | Valencia | 46009 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 413 45 | Sweden |
| Norrlands Universitetssjukhus | Umeå | 901 85 | Sweden |
| Kantonsspital Baden | Baden | 5404 | Switzerland |
| Universitaetsspital Basel | Basel | 4052 | Switzerland |
| Ospedale Regionale di Bellinzona e Vali | Mendrisio | 6850 | Switzerland |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Ankara Etlik Sehir Hastanesi | Ankara | 06200 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi | Ankara | 06520 | Turkey (Türkiye) |
| Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi | Ankara | 06560 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Ankara | 06800 | Turkey (Türkiye) |
| Bagcilar Medipol Mega Universite Hastanesi | Istanbul | 34214 | Turkey (Türkiye) |
| Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi | Istanbul | 34722 | Turkey (Türkiye) |
| Marmara Universitesi Tip Fakultesi Hastanesi | Istanbul | 34890 | Turkey (Türkiye) |
| Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi | Izmir | 35110 | Turkey (Türkiye) |
| Izmir Ekonomi Universitesi Medical Point Hastanesi | Izmir | 35575 | Turkey (Türkiye) |
| Kocaeli Universitesi Tip Fakultesi Hastanesi | Kocaeli | 41380 | Turkey (Türkiye) |
| Medical Park Seyhan Hastanesi | Mersin | 33200 | Turkey (Türkiye) |
| Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi | Samsun | 55200 | Turkey (Türkiye) |
| Guys Hospital | London | SE1 9RT | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722655 | AMG 757 |
Not provided
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