Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
- Conditions
- Limited Stage Small Cell Lung CancerSmall Cell Lung Cancer
- Interventions
- Drug: Placebo
- Registration Number
- NCT06117774
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
-Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- Histologically or cytologically confirmed small-cell lung cancer (SCLC).
- Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
- Has completed chemoradiotherapy without progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1.) (ie, achieved complete response [CR], partial response [PR], or stable disease [SD]).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Minimum life expectancy of 12 weeks.
- Adequate organ function.
- Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.
-Participants are excluded from the study if any of the following criteria apply:
Disease Related
- Extensive-stage SCLC (ES-SCLC).
- Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
- History of other malignancy within the past 2 years, with certain exceptions.
- History of solid organ transplantation.
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
- Exclusion of human immunodeficiency virus (HIV) and/or hepatitis infection based on criteria per protocol.
- Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
Prior/Concomitant Therapy
- Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic radiotherapy with chemotherapy) during chemoradiation.
- Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
- Prior history of severe or life-threatening events from any immune-mediated therapy.
- Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
- Major surgical procedures within 28 days prior to first dose of study treatment.
- Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.
Prior/Concurrent Clinical Study Experience
• Treatment in an alternative investigational trial within 28 days prior to enrollment.
Other Exclusions
- Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of study treatment.
- Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.
- Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
- Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
- Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of study treatment.
- Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment.
- Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tarlatamab Tarlatamab 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 Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).
- Primary Outcome Measures
Name Time Method PFS as Determined by Blinded Independent Central Review (BICR) Up to approximately 6 years
- Secondary Outcome Measures
Name Time Method 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 Objective Response (OR) Rate Up to approximately 6 years Disease Control (DC) Rate Up to approximately 6 years Duration of Response (DOR) Up to approximately 6 years PFS at 6 months, 1 year, 2 years 6 months, 1 year, 2 years Overall Survival (OS) Over the Whole Trial Up to approximately 6 years PFS Determined by Investigator Assessment Up to approximately 6 years
Trial Locations
- Locations (192)
Saint Lukes Hospital SA
🇬🇷Thessaloniki, Greece
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
University of California Los Angeles
🇺🇸Santa Monica, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Boca Raton Clinical Research Global South Florida
🇺🇸Plantation, Florida, United States
University of Louisville James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Our Lady of the Lake Cancer Institute
🇺🇸Baton Rouge, Louisiana, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Montefiore Einstein Center for Cancer Care
🇺🇸Bronx, New York, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
🇺🇸New York, New York, United States
Perlmutter Cancer Center at New York University Langone Hospital - Long Island
🇺🇸New York, New York, United States
FirstHealth Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Spokenword Clinical Trials
🇺🇸Easton, Pennsylvania, United States
Renovatio Clinical
🇺🇸The Woodlands, Texas, United States
US Oncology Research Investigational Products Center
🇺🇸The Woodlands, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
West Virginia University Health Sciences Center
🇺🇸Morgantown, West Virginia, United States
Hospital Italiano de La Plata
🇦🇷La Plata, Buenos Aires, Argentina
Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo
🇦🇷Cordoba, Córdoba, Argentina
Hospital Aleman Buenos Aires
🇦🇷Caba, Distrito Federal, Argentina
Clinica Viedma
🇦🇷Viedma, Río Negro, Argentina
Sanatorio 9 de Julio Cice 9 de Julio
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Instituto Argentino de Diagnóstico y Tratamiento
🇦🇷Buenos Aires, Argentina
Fundacion Respirar
🇦🇷Buenos Aires, Argentina
Port Macquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Medizinische Universitaet Graz
🇦🇹Graz, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
🇦🇹Wien, Austria
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Oncoclinicas Onco Vida Distrito Federal
🇧🇷Brasilia, Distrito Federal, Brazil
Hospital Santa Rita
🇧🇷Vitoria, Espírito Santo, Brazil
Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner
🇧🇷Curitba, Paraná, Brazil
Londrina Cancer Hospital
🇧🇷Londrina, Paraná, Brazil
Liga Norte-Riograndense Contra O Cancer
🇧🇷Natal, Rio Grande Do Norte, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Cipo - Centro Integrado de Pesquisa em Oncologia
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Centro de pesquisa em oncologia Hospital Ana Nery
🇧🇷Santa Cruz do Sul, Rio Grande Do Sul, Brazil
Centro Catarinense de Pesquisa LTDA
🇧🇷Blumenau, Santa Catarina, Brazil
Fundacao Pio 12 Hospital de Amor de Barretos
🇧🇷Barretos, São Paulo, Brazil
Fundacao Amaral Carvalho
🇧🇷Jau, São Paulo, Brazil
Cepho
🇧🇷Santo Andre, São Paulo, Brazil
Instituto Dor de Pesquisa e Ensino
🇧🇷Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
🇧🇷São Paulo, Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
🇧🇬Panagyurishte, Bulgaria
Complex Oncology Center Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
Complex Oncology Center Shumen EOOD
🇧🇬Shumen, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed OOD
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
🇧🇬Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
🇧🇬Sofia, Bulgaria
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Northern Jiangsu Peoples hospital
🇨🇳Yangzhou, Jiangsu, China
Jiangxi Cancer hospital
🇨🇳Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Cancer Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Zhejiang Taizhou Hospital
🇨🇳Taizhou, Zhejiang, China
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
🇨🇴Bogota, Cundinamarca, Colombia
Instituto Medico de Alta Tecnologia sas - Imat sas
🇨🇴Monteria, Córdoba, Colombia
Oncologos del Occidente SAS
🇨🇴Pereira, Risaralda, Colombia
Fundacion cardiovascular de Colombia
🇨🇴Bucaramanga, Santander, Colombia
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
🇫🇷Lille, France
Centre Hospitalier Universitaire Nord
🇫🇷Marseille Cedex 20, France
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
🇫🇷Nice Cedex 01, France
Hopital Bichat Claude Bernard
🇫🇷Paris, France
Hopital Nord Ouest Villefranche sur Saone
🇫🇷Villefranche Sur Saone Cedex, France
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitaetsmedizin Goettingen
🇩🇪Goettingen, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Agios Savvas Anticancer Hospital
🇬🇷Athens, Greece
Henry Dunant Hospital Center
🇬🇷Athens, Greece
Sotiria General Hospital
🇬🇷Athens, Greece
Attikon University Hospital
🇬🇷Athens, Greece
Metropolitan Hospital
🇬🇷Athens, Greece
European Interbalkan Medical Center
🇬🇷Thessaloniki, 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, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
IRCCS Istituto Oncologico Europeo
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
🇮🇹Orbassano, Italy
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
🇮🇹Perugia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano MI, Italy
Ospedale San Giuseppe Moscati
🇮🇹Statte, Italy
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-shi, Ehime, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo-shi, Hokkaido, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Sendai Kousei Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata-shi, Niigata, Japan
Okayama University Hospital
🇯🇵Okayama-shi, Okayama, Japan
Kansai Medical University Hospital
🇯🇵Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka-Shi, Saitama, Japan
Saitama Cancer Center
🇯🇵Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
Dokkyo Medical University Hospital
🇯🇵Shimotsuga-gun, Tochigi, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Japan
Chungbuk National University Hospital
🇰🇷Cheongju Chungbuk, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si Gyeonggi-do, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju-si, Korea, Republic of
Cha Bundang Medical Center, Cha University
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Oncare
🇲🇽Ciudad de México, Distrito Federal, Mexico
Phylasis Clinicas Research Toluca
🇲🇽Toluca, Mexico
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej
🇵🇱Bystra, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Uniwerystecki Szpital Kliniczny Nr 4 w Lublinie
🇵🇱Lublin, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
🇵🇱Poznan, Poland
Szpital Specjalistyczny w Prabutach Spolka z Ograniczoną Odpowiedzialnoscia
🇵🇱Prabuty, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
🇵🇱Przemysl, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
🇵🇱Warszawa, Poland
Unidade Local de Saude de Braga, EPE
🇵🇹Braga, Portugal
Hospital da Luz, SA
🇵🇹Lisboa, Portugal
Hospital Cuf porto
🇵🇹Porto, Portugal
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
🇷🇴Bucuresti, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
🇷🇴Cluj Napoca, Romania
Centrul de Oncologie Sf Nectarie SRL
🇷🇴Craiova, Romania
Institutul Regional de Oncologie Iasi
🇷🇴Iasi, Romania
Spitalul Municipal Ploiesti
🇷🇴Ploiesti, Romania
SC Oncomed SRL
🇷🇴Timisoara, Romania
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Icon - Mount Alvernia
🇸🇬Singapore, Singapore
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Andalucía, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Andalucía, Spain
Hospital Universitario Insular de Gran Canaria
🇪🇸Las Palmas de Gran Canaria, Canarias, Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Cataluña, Spain
Hospital del Mar
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Instituto Valenciano de Oncologia
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Galicia, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Sahlgrenska Universitetssjukhuset
🇸🇪Goteborg, Sweden
Norrlands Universitetssjukhus
🇸🇪Umea, Sweden
Kantonsspital Baden
🇨🇭Baden, Switzerland
Universitaetsspital Basel
🇨🇭Basel, Switzerland
Ospedale Regionale di Bellinzona e Vali
🇨🇭Mendrisio, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Memorial Ankara Hastanesi
🇹🇷Ankara, Turkey
Ankara Bilkent Sehir Hastanesi
🇹🇷Ankara, Turkey
Bagcilar Medipol Mega Universite Hastanesi
🇹🇷Istanbul, Turkey
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
🇹🇷Istanbul, Turkey
Marmara Universitesi Tip Fakultesi Hastanesi
🇹🇷Istanbul, Turkey
Izmir Ekonomi Universitesi Medical Point Hastanesi
🇹🇷Izmir, Turkey
Kocaeli Universitesi Tip Fakultesi Hastanesi
🇹🇷Kocaeli, Turkey
Medical Park Seyhan Hastanesi
🇹🇷Mersin, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
🇹🇷Samsun, Turkey
Guys Hospital
🇬🇧London, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom