Lung Cancer Clinical Trial

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Summary

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
Histologically or cytologically confirmed relapsed/refractory SCLC.
Participants who progressed or recurred following 1 platinum-based regimen.
Provision of evaluable tumor sample for central testing.
Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
Minimum life expectancy of 12 weeks.
Adequate organ function.

Exclusion Criteria:

Disease Related

Untreated or symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
Diagnosis or evidence of leptomeningeal disease.
Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.

Other Medical Conditions

Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
History of solid organ transplantation.
History of other malignancy within the past 2 years, with exceptions defined in the protocol.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to first dose of study treatment.
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
Exclusion of HIV and hepatitis infection based on criteria per protocol.
Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
Evidence of interstitial lung disease or active, non-infectious pneumonitis.

Prior/Concomitant Therapy

Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial.
Prior therapy with any selective inhibitor of the DLL3 pathway.
Participant received more than one prior systemic therapy regimen for SCLC.
Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
Major surgical procedures within 28 days prior to first dose of study treatment.
Live and live-attenuated vaccines within 14 days prior to the start of study treatment.
Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

Diagnostic Assessments

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.

Other Exclusions

Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 72 days after the last dose of tarlatamab.
Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of tarlatamab.
Female participants planning to become pregnant or donate eggs while on study through 72 days after the last dose of tarlatamab.
Female participants of childbearing potential with a positive pregnancy test assessed at screening by a 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 132 days after the last dose of tarlatamab.
Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 132 days after the last dose of tarlatamab.
Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 days after the last dose of tarlatamab.
Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.
Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.
Participant has known sensitivity or is contraindicated 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.
History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician that would pose a risk to the subject safety or interfere with the study evaluation.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT05740566

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 136 Locations for this study

See Locations Near You

Alaska Oncology and Hematology LLC
Anchorage Alaska, 99508, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Indiana U Simon Cancer Center
Indianapolis Indiana, 46202, United States
Pikeville Medical Center
Pikeville Kentucky, 41501, United States
Our Lady of the Lake Cancer Institute
Baton Rouge Louisiana, 70808, United States
Trinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor Michigan, 48106, United States
New York University Langone Health
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
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58102, United States
Sanford Oncology Clinic and Pharmacy
Sioux Falls South Dakota, 57104, United States
University of Tennessee Medical Center Knoxville
Knoxville Tennessee, 37920, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Swedish Cancer Institute Medical Oncology
Edmonds Washington, 98026, United States
The Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Cemic
Ciudad Autonoma de Buenos Aires Buenos Aires, C1431, Argentina
Hospital Universitario Austral
Pilar Buenos Aires, B1629, Argentina
Clinica Viedma
Viedma Río Negro, R8500, Argentina
Sanatorio Parque SA
Rosario Santa Fe, 2000, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADT
Buenos Aires , C1122, Argentina
Sanatorio Allende
Córdoba , X5000, Argentina
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
Calvary Mater Newcastle Hospital
Waratah New South Wales, 2298, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt , 3500, Belgium
AZ Delta Campus Rumbeke
Roeselare , 8800, Belgium
Vitaz campus Sint-Niklaas Moerland
Sint-Niklaas , 9100, Belgium
Hospital Santa Izabel
Salvador Bahia, 40050, Brazil
Instituto de Ensino e Pesquisa do Hospital da Bahia
Salvador Bahia, 41810, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal Rio Grande Do Norte, 59075, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijui Rio Grande Do Sul, 98700, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Hospital de Amor Amazonia
Porto Velho Rondônia, 76834, Brazil
Beneficencia Portuguesa de Sao Paulo
Sao Paulo São Paulo, 01323, Brazil
Oncologia Rede D Or
Sao Paulo São Paulo, 04502, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto São Paulo, 15090, Brazil
Anhui Chest Hospital
Hefei Anhui, 23002, China
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing Beijing, 10001, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
The Second Affiliated Hospital of Army Military Medical University
Chongqing Chongqing, 40003, China
Army Special Medical Center of People's Liberation Army
Chongqing Chongqing, 40004, China
Fujian Medical University Union Hospital
Fuzhou Fujian, 35000, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou Fujian, 35002, China
Sun Yat-Sen University Cancer Center
Guangzhou Guangdong, 51006, China
Jiangmen Central Hospital
Jiangmen Guangdong, 52903, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin Heilongjiang, 15000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan Hubei, 43003, China
The First Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
Jinan Central Hospital
Jinan Shandong, 25001, China
Shandong Tumor Hospital
Jinan Shandong, 25011, China
Linyi Cancer Hospital
Linyi Shandong, 27603, China
Shanxi Province Cancer Hospital
Taiyuan Shanxi, 03001, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31000, China
Taizhou Peoples Hospital
Taizhou Zhejiang, 31709, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou Zhejiang, 32501, China
Beijing Chest Hospital, Capital Medical University
Beijing , 10114, China
Weihai Municipal Hospital
Weihai , 26420, China
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Nemocnice Agel Ostrava-Vitkovice as
Ostrava-Vitkovice , 703 0, Czechia
Rigshospitalet
Copenhagen , 2100, Denmark
Centre Hospitalier Lyon Sud
Pierre-Benite cedex , 69495, France
Universitaetsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Universitaetsklinikum Essen
Essen , 45147, Germany
Universitaetsklinikum Wuerzburg
Wuerzburg , 97078, Germany
Saint Savas Hospital
Athens , 11522, Greece
Henry Dunant Hospital Center
Athens , 11526, Greece
Alexandra Hospital
Athens , 11528, Greece
University Hospital of Heraklion
Heraklion - Crete , 71500, Greece
Olympion Therapeftirio General Clinic Of Patras
Patra , 26443, Greece
Saint Luke Hospital
Thessaloniki , 55236, Greece
European Interbalkan Medical Center
Thessaloniki , 57001, Greece
Matrai Gyogyintezet
Gyongyos , 3200, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabanya , 2800, Hungary
Torokbalinti Tudogyogyintezet
Torokbalint , 2045, Hungary
Rambam Medical Center
Haifa , 31096, Israel
Hadassah Ein-Kerem Medical Center
Jerusalem , 91120, Israel
Rabin Medical Center
Petah Tikva , 49414, Israel
Humanitas Gavazzeni
Bergamo , 24125, Italy
National Hospital Organization Nagoya Medical Center
Nagoya-shi Aichi, 460-0, Japan
Aichi Cancer Center
Nagoya-shi Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama-shi Ehime, 791-0, Japan
Kurume University Hospital
Kurume-shi Fukuoka, 830-0, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo-shi Hokkaido, 003-0, Japan
Hyogo Cancer Center
Akashi-shi Hyogo, 673-8, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama-shi Kanagawa, 241-8, Japan
Sendai Kousei Hospital
Sendai-shi Miyagi, 980-0, Japan
Niigata Cancer Center Hospital
Niigata-shi Niigata, 951-8, Japan
Okayama University Hospital
Okayama-shi Okayama, 700-8, Japan
Kansai Medical University Hospital
Hirakata-shi Osaka, 573-1, Japan
Osaka International Cancer Institute
Osaka-shi Osaka, 541-8, Japan
Kindai University Hospital
Osakasayama-shi Osaka, 589-8, Japan
Saitama Medical University International Medical Center
Hidaka-Shi Saitama, 350-1, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
Wakayama Medical University Hospital
Wakayama-shi Wakayama, 641-8, Japan
Chungbuk National University Hospital
Cheongju Chungbuk , 28644, Korea, Republic of
National Cancer Center
Goyang-si Gyeonggi-do , 10408, Korea, Republic of
Gachon University Gil Hospital
Incheon , 21565, Korea, Republic of
Gyeongsang National University Hospital
Jinju-si , 52727, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
Seoul , 06591, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Hospital Tengku Ampuan Afzan
Kuantan Pahang, 25100, Malaysia
Sarawak General Hospital
Kuching Sarawak, 93586, Malaysia
University Malaya Medical Centre
Kuala Lumpur Wilayah Persekutuan, 59100, Malaysia
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
Krakow , 31-82, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
Poznan , 60-56, Poland
Hospital da Luz, SA
Lisboa , 1500-, Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj Napoca , 40001, Romania
Centrul de Oncologie Sf Nectarie SRL
Craiova , 20054, Romania
SC Oncomed SRL
Timisoara , 30023, Romania
National Cancer Centre Singapore
Singapore , 16858, Singapore
Tan Tock Seng Hospital
Singapore , 30843, Singapore
Kantonsspital Graubuenden
Chur , 7000, Switzerland
Hopitaux universitaires de Geneve
Geneve 14 , 1211, Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen , 9007, Switzerland
Kantonsspital Winterthur
Winterthur , 8401, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 80756, Taiwan
Veterans General Hospital - Taichung
Taichung , 40705, Taiwan
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Ankara Bilkent Sehir Hastanesi
Ankara , 06800, Turkey
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli , 20070, Turkey
Medipol Mega Universite Hastanesi
Istanbul , 34214, Turkey
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul , 34722, Turkey
Ege Universitesi Tip Fakultesi Hastanesi
Izmir , 35100, Turkey
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir , 35575, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya , 44280, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT05740566

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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