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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511021-58 | EudraCT Number |
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This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Exploration Combination Regimen 1 | Experimental | Tarlatamab+Atezolizumab+Carboplatin+Etoposide |
|
| Part 2: Dose Exploration Combination Regimen 2 | Experimental | Tarlatamab+Atezolizumab+Carboplatin+Etoposide |
|
| Part 3: Dose Exploration Combination Regimen 3 | Experimental | Tarlatamab+Atezolizumab+Carboplatin+Etoposide |
|
| Part 4: Dose Expansion | Experimental | Expansion of Part 1, Part 2, or Part 3 with Atezolizumab |
|
| Part 5: Dose Exploration Maintenance | Experimental | Tarlatamab+Atezolizumab |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarlatamab | Drug | Tarlatamab will be administered as an intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with a Dose Limiting Toxicity (DLT) | 24 months | |
| Number of Participants with Treatment-emergent Adverse Events (TEAE) | 24 months | |
| Number of Participants with Treatment-related Adverse Events | 24 months | |
| Number of Participants with Clinically Significant Changes in Vital Signs | 24 months | |
| Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements | 24 months | |
| Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Progression-free Survival (PFS) | 24 months | |
| Objective Response (OR) | Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California, Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40934933 | Background | Paulson KG, Lau SCM, Ahn MJ, Moskovitz M, Pogorzelski M, Hafliger S, Parkes A, Zhang Y, Hamidi A, Thompson CG, Wermke M. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. Lancet Oncol. 2025 Oct;26(10):1300-1311. doi: 10.1016/S1470-2045(25)00480-2. Epub 2025 Sep 8. |
| 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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| Part 6: Dose Expansion Maintenance | Experimental | Expansion of Part 5 with Atezolizumab |
|
| Part 7: Dose Expansion | Experimental | Expansion of Part 1, 2, or 3 with Durvalumab |
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| Part 8: Dose Expansion Maintenance | Experimental | Expansion of Part 5 with Durvalumab |
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| Part 9: Dose Expansion Maintenance | Experimental | Expansion with Tarlatamab+Durvalumab |
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| Carboplatin | Drug | Carboplatin will be administered as an intravenous (IV) infusion. |
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| Etoposide | Drug | Etoposide will be administered as an intravenous (IV) infusion. |
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| Atezolizumab | Drug | Atezolizumab will be administered as an intravenous (IV) infusion. |
|
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| Durvalumab | Drug | Durvalumab will be administered as an intravenous (IV) infusion. |
|
| Duration of Response (DOR) | 24 months |
| Disease Control Rate(DCR) | 24 months |
| Overall Survival (OS) | 24 months |
| Serum Concentration of Tarlatamab | 24 months |
| Christiana Care Health Services |
| Newark |
| Delaware |
| 19713 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| New York University Grossman School of Medicine and New York University Langone Hospitals | New York | New York | 10016 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Swedish Cancer Institute Medical Oncology | Seattle | Washington | 98104 | United States |
| West Virginia University Health Sciences Center | Morgantown | West Virginia | 26506 | United States |
| Chris OBrien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Algemeen Ziekenhuis Maria Middelares | Ghent | 9000 | Belgium |
| Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | 3500 | Belgium |
| AZ Delta Campus Rumbeke | Roeselare | 8800 | Belgium |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| CHU de Quebec Hopital de l Enfant Jesus | Québec | Quebec | G1R 2J6 | Canada |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Centre Leon Berard | Lyon | 69373 | France |
| Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec | Saint-Herblain | 44800 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Universitaetsklinikum Dresden | Dresden | 01307 | Germany |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Hadassah Ein-Kerem Medical Center | Jerusalem | 9112001 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Azienda Ospedaliera Universitaria Renato Dulbecco | Catanzaro | 88100 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori | Monza (MB) | 20900 | Italy |
| Istituto Nazionale Tumori Regina Elena | Rome | 00144 | Italy |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol | Badalona | Catalonia | 08916 | Spain |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Universitaetsspital Basel | Basel | 4031 | Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C000722655 | AMG 757 |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| C000594389 | atezolizumab |
| C000613593 | durvalumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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