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JOURNAL ONKOLOGIE – STUDIE
DeLLphi-304

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

Rekrutierend

NCT-Nummer:
NCT05740566

Studienbeginn:
Mai 2023

Letztes Update:
25.04.2024

Wirkstoff:
Tarlatamab, Lurbinectedin, Topotecan, Amrubicin

Indikation (Clinical Trials):
Lung Neoplasms, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 210)

Charite Universitaetsmedizin Berlin, Campus Virchow
13353 Berlin
(Berlin)
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Universitaetsklinikum Dresden
01307 Dresden
(Sachsen)
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Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
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Asklepios Fachkliniken Muenchen Gauting
82130 Gauting
(Bayern)
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LungenClinic Grosshansdorf GmbH
22927 Grosshansdorf
(Schleswig-Holstein)
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Universitaetsklinikum Koeln
50937 Koeln
(Nordrhein-Westfalen)
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Brustzentrum Robert-Bosch-Krankenhaus
Auerbachstraße 110
70376 Stuttgart
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Universitaetsklinikum Wuerzburg
97078 Wuerzburg
(Bayern)
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Alaska Oncology and Hematology
99508 Anchorage
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University of Arkansas for Medical Sciences
72205 Little Rock
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University of California Los Angeles
90404 Santa Monica
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Northwestern University
60611 Chicago
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University of Illinois at Chicago
60612 Chicago
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Indiana U Simon Cancer Center
46202 Indianapolis
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Pikeville Medical Center
41501 Pikeville
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Our Lady of the Lake Cancer Institute
70808 Baton Rouge
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Trinity Health Saint Joseph Mercy Ann Arbor
48106 Ann Arbor
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University of Minnesota Cancer Center
55455 Minneapolis
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University of Missouri Health Care
65212 Columbia
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Summit Medical Group, Overlook Oncology Center
91010 Summit
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New York University Langone Health
10016 New York
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Perlmutter Cancer Center at New York University Langone Hospital----Long Island
10016 New York
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Memorial Sloan Kettering Cancer Center
10021 New York
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Sanford Roger Maris Cancer Center
58102 Fargo
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Sanford Oncology Clinic and Pharmacy
57104 Sioux Falls
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University of Tennessee Medical Center Knoxville
37920 Knoxville
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Virginia Commonwealth University
23298 Richmond
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Swedish Cancer Institute Medical Oncology
98026 Edmonds
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The Medical College of Wisconsin
53226 Milwaukee
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Cemic
C1431FWO Ciudad Autonoma de Buenos Aires
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Hospital Universitario Austral
B1629ODT Pilar
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Instituto Argentino de Diagnostico y Tratamiento IADT
C1122AAL Buenos Aires
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Calvary Mater Newcastle Hospital
2298 Waratah
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Jessa Ziekenhuis - Campus Virga Jesse
3500 Hasselt
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Vitaz campus Sint-Niklaas Moerland
9100 Sint-Niklaas
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41810-011 Salvador
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Liga Norte-Riograndense Contra O Cancer
59075-740 Natal
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Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
98700-000 Ijui
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90610-000 Porto Alegre
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76834-899 Porto Velho
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01323-900 Sao Paulo
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01246-000 São Paulo
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London Health Sciences Centre
N6A 5W9 London
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Princess Margaret Cancer Centre
M5G 2M9 Toronto
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Beijing Tongren Hospital affiliated to Capital Medical University
100010 Beijing
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400037 Chongqing
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400042 Chongqing
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Fujian Medical University Union Hospital
350001 Fuzhou
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Mengchao Hepatobiliary Hospital of Fujian Medical University
350025 Fuzhou
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Sun Yat-Sen University Cancer Center
510060 Guangzhou
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Affiliated Cancer Hospital of Harbin Medical University
150000 Harbin
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
430022 Wuhan
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Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
430030 Wuhan
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The First Affiliated Hospital of Nanchang University
330006 Nanchang
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Fudan University Shanghai Cancer Center
200032 Shanghai
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Shanxi Province Cancer Hospital
030013 Taiyuan
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The Second Affiliated Hospital Zhejiang University School of Medicine
310003 Hangzhou
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The First Affiliated Hospital of Wenzhou Medical University
325015 Wenzhou
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Beijing Chest Hospital, Capital Medical University
101149 Beijing
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Nemocnice Agel Ostrava-Vitkovice as
703 00 Ostrava-Vitkovice
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Vseobecna fakultni nemocnice v Praze
128 08 Praha 2
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38700 Grenoble
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59037 Lille Cedex
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87042 Limoges Cedex
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13915 Marseille Cedex 20
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69495 Pierre-Benite cedex
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35033 Rennes Cedex 9
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67091 Strasbourg Cedex
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31059 Toulouse Cedex 9
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Thoracic General Hospital Of Athens Sotiria
11527 Athens
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71500 Heraklion - Crete
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Olympion Therapeftirio General Clinic Of Patras
26443 Patra
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European Interbalkan Medical Center
57001 Thessaloniki
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Orszagos Koranyi Pulmonologiai Intezet
1121 Budapest
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Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
8000 Szekesfehervar
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Komarom-Esztergom Varmegyei Szent Borbala Korhaz
2800 Tatabanya
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Reformatus Pulmonologiai Centrum
2045 Torokbalint
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Hadassah Ein-Kerem Medical Center
9112001 Jerusalem
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Azienda Ospedaliera Universitaria Renato Dulbecco
88100 Catanzaro
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Ospedale Policlinico San Martino IRCCS
16132 Genova
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
47014 Meldola (FC)
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Azienda Ospedaliera Universitaria San Luigi Gonzaga
10043 Orbassano
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00144 Roma
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National Hospital Organization Nagoya Medical Center
460-0001 Nagoya-shi
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National Cancer Center Hospital East
277-8577 Kashiwa-shi
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National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama-shi
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Kurume University Hospital
830-0011 Kurume-shi
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National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo-shi
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Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
241-8515 Yokohama-shi
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Niigata Cancer Center Hospital
951-8566 Niigata-shi
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Okayama University Hospital
700-8558 Okayama-shi
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Kansai Medical University Hospital
573-1191 Hirakata-shi
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Osaka International Cancer Institute
541-8567 Osaka-shi
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Kindai University Hospital
589-8511 Osakasayama-shi
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Saitama Medical University International Medical Center
350-1298 Hidaka-Shi
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Juntendo University Hospital
113-8431 Bunkyo-ku
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National Cancer Center Hospital
104-0045 Chuo-ku
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The Cancer Institute Hospital of Japanese Foundation for Cancer Research
135-8550 Koto-ku
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Wakayama Medical University Hospital
641-8510 Wakayama-shi
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Chungbuk National University Hospital
28644 Cheongju Chungbuk
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National Cancer Center
10408 Goyang-si Gyeonggi-do
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Gachon University Gil Hospital
21565 Incheon
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Gyeongsang National University Hospital
52727 Jinju-si
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Seoul National University Bundang Hospital
13620 Seongnam-si, Gyeonggi-do
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Severance Hospital Yonsei University Health System
03722 Seoul
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Asan Medical Center
05505 Seoul
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Samsung Medical Center
06351 Seoul
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The Catholic University of Korea Seoul St Marys Hospital
06591 Seoul
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Ulsan University Hospital
44033 Ulsan
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Hospital Tengku Ampuan Afzan
25100 Kuantan
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59100 Kuala Lumpur
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9713 GZ Groningen
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2333 ZA Leiden
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3015 GD Rotterdam
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3584 CX Utrecht
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43-360 Bystra
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Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
31-826 Krakow
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60-569 Poznan
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Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
4464-513 Matosinhos
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Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
400015 Cluj Napoca
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Centrul de Oncologie Sf Nectarie SRL
200542 Craiova
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Institutul Regional de Oncologie Iasi
700483 Iasi
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National Cancer Centre Singapore
168583 Singapore
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29011 Malaga
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50009 Zaragoza
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08035 Barcelona
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08041 Barcelona
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Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera
15006 A Coruña
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28222 Majadahonda
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28041 Madrid
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1211 Geneve 14
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8401 Winterthur
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Kaohsiung Medical University Chung-Ho Memorial Hospital
80756 Kaohsiung
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40705 Taichung
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70403 Tainan
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10002 Taipei
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11217 Taipei
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Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
06560 Ankara
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06800 Ankara
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20070 Denizli
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Medipol Mega Universite Hastanesi
34214 Istanbul
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34722 Istanbul
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35100 Izmir
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35575 Izmir
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44280 Malatya
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M20 4BX Manchester
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Studien-Informationen

Brief Summary:

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on

prolonging overall survival (OS).

Ein-/Ausschlusskriterien

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 SCLC with demonstrated progression or

relapse.

- Participants who progressed or recurred following 1 platinum-based regimen.

- 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

- 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.

- Presence or history of viral 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 or participation in any tarlatamab or any other

DLL3 targeted agent clinical 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, with exceptions defined in the protocol.

- 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.

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - Up to approximately 4 years)



Secondary outcome:

1. Progression Free Survival (PFS) (Time Frame - Up to approximately 4 years)

2. Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - Up to approximately 4 years)

3. Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13) (Time Frame - Up to approximately 4 years)

4. Overall Response (OR) (Time Frame - Up to approximately 4 years)

5. Disease Control (DC) (Time Frame - Up to approximately 4 years)

6. Duration of Response (DOR) (Time Frame - Up to approximately 4 years)

7. PFS (Time Frame - 1 year)

8. OS (Time Frame - 1 year, 2 years and 3 years)

9. Incidence of Treatment-Emergent Adverse Events (TEAE) (Time Frame - Up to approximately 4 years)

10. Serum Concentrations of Tarlatamab (Time Frame - Up to 1 year)

11. Number of Participants Who Experience Anti-tarlatamab Antibodies (Time Frame - Up to 1 year)

12. Change from Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF) (Time Frame - Up to approximately 4 years)

13. Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS) (Time Frame - Up to approximately 4 years)

14. Change from Baseline in Patient Perceived Health Using Visual Analog Scale (VAS) (Time Frame - Up to approximately 4 years)

15. Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE) (Time Frame - Up to approximately 4 years)

16. Change from Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire (Time Frame - Up to approximately 4 years)

17. Change from Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire (Time Frame - Up to approximately 4 years)

18. Change from Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire (Time Frame - Up to approximately 4 years)

Studien-Arme

  • Experimental: Tarlatamab
    Participants will receive tarlatamab as an intravenous (IV) infusion.
  • Active Comparator: Standard of Care
    Participants will receive treatment per local standard of care (SOC).

Geprüfte Regime

  • Tarlatamab (AMG 757):
    Tarlatamab will be administered as an IV infusion.
  • Lurbinectedin:
    Lurbinectedin will be administered per local SOC.
  • Topotecan:
    Topotecan will be administered per local SOC.
  • Amrubicin:
    Amrubicin will be administered per local SOC.

Quelle: ClinicalTrials.gov


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

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