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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522888-15-00 | EU Trial (CTIS) Number |
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The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Exploration (Part 1) | Experimental | Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV). |
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| Dose Expansion (Part 2) | Experimental | ZL-1310 will be administered IV at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV. |
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| Triplet Combination (Part 3) | Experimental | ZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-1310 | Drug | ZL-1310 will be administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 3.5 years | |
| Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Up to 3.5 years | |
| Duration of Response (DOR) per RECIST v1.1 | Up to 3.5 years | |
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Inclusion Criteria:
Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Cancer Institute | Recruiting | New York | New York | 10016 | 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.
Data sharing requests relating to this trial will be considered beginning 18 months after the trial 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 trial.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials 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. |
|
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| Durvalumab | Drug | Durvalumab will be administered as an IV infusion. |
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| Time to Response (TTR) per RECIST v1.1 |
| Up to 3.5 years |
| Disease Control Rate (DCR) per RECIST v1.1 | Up to 3.5 years |
| Progression-free Survival (PFS) per RECIST v1.1 | Up to 3.5 years |
| Time to Progression (TTP) per RECIST v1.1 | Up to 3.5 years |
| Time to Subsequent Therapy | Up to 3.5 years |
| Overall survival (OS) | Up to 3.5 years |
| Serum Tarlatamab Concentrations | Up to Week 36 |
| Baptist Cancer Center |
| Recruiting |
| Memphis |
| Tennessee |
| 38120 |
| United States |
| Next Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| Adana Sehir Egitim ve Arastirma Hastanesi | Recruiting | Adana | 01370 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
| Izmir Ekonomi Universitesi Medical Point Hastanesi | Recruiting | Izmir | 35575 | Turkey (Türkiye) |
| 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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