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| Name | Class |
|---|---|
| MediLink | UNKNOWN |
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The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Exploration (Part 1) | Experimental | Multiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing. |
|
| Dose Expansion (Part 2) | Experimental | YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose. |
|
| Triplet Combination (Part 3) | Experimental | YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) administered IV at a fixed dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL201 | Drug | YL201 will be administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose-limiting toxicities (DLTs) | Up to Day 21 | |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 3.5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Up to 3.5 Years | |
| Duration of Response (DOR) per RECIST 1.1 | Up to 3.5 Years | |
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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 |
|---|---|---|---|---|---|---|
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | 92618 | United States | ||
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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 .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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| Tarlatamab | Drug | Tarlatamab will be administered as an IV infusion. |
|
| Durvalumab | Drug | Durvalumab will be administered as an IV infusion. |
|
| Time to Response (TTR) per RECIST 1.1 |
| Up to 3.5 Years |
| Disease Control Rate (DCR) per RECIST 1.1 | Up to 3.5 Years |
| Progression-free Survival (PFS) per RECIST 1.1 | Up to 3.5 Years |
| Time to Progression (TTP) per RECIST 1.1 | Up to 3.5 Years |
| Time to Subsequent Therapy | Up to 3.5 Years |
| Overall Survival (OS) | Up to 3.5 Years |
| Maximum Serum Concentration (Cmax) of Tarlatamab | Up to Week 36 |
| Minimum Serum Concentration (Cmin) of Tarlatamab | Up to Week 36 |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for Tarlatamab | Up to Week 36 |
| Half-life (t1/2) of Tarlatamab | Up to Week 36 |
| Yale New Haven Hospital |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Sanford Oncology Clinic and Pharmacy | Sioux Falls | South Dakota | 54104 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| CHU de Quebec Hopital de l Enfant Jesus | Québec | Quebec | G1J 1Z4 | Canada |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 611135 | China |
| Fujian Cancer Hospital | Fuzhou | 350011 | China |
| Institut Bergonie | Bordeaux | 33000 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Institut Universitaire du Cancer Toulouse Oncopole | Toulouse | 31059 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Henry Dunant Hospital Center | Athens | 11526 | Greece |
| Alexandra Hospital | Athens | 11528 | Greece |
| European Interbalkan Medical Center | Thessaloniki | 57001 | Greece |
| Iatriko Diavalkaniko Thessalonikis | Thessaloniki | 57001 | Greece |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Clinexpert Kft Bugat Pal Korhaz | Gyöngyös | 3200 | Hungary |
| Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS | Candiolo to | 10060 | Italy |
| Istituto Romagnolo per lo Studio dei Tumori Dino Amadori | Meldola (FC) | 47014 | Italy |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08041 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| 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 |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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