Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

Phase 3

Recruiting

• Conditions: Extensive-Stage Small-Cell Lung Cancer; Small-Cell Lung Cancer
• Interventions: Drug: Tarlatamab; Drug: Durvalumab

• Registration Number: NCT06211036
• Lead Sponsor: Amgen

Brief Summary

The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Study Start: 2024-06-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-04
• Primary Completion: 2027-07-05
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tarlatamab in Combination With Durvalumab	Tarlatamab	Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
Tarlatamab in Combination With Durvalumab	Durvalumab	Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
Durvalumab Alone	Durvalumab	Participants will receive durvalumab Q4W alone.

Primary Outcome Measures

Name	Time	Method
OS	Up to approximately 3 years

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Up to approximately 3 years
Duration of Response (DoR)	Up to approximately 3 years
PFS at 2 Years	2 years
OS at 6 Months	6 months
OS at 1 Year	1 year
OS at 2 Years	2 years
OS at 3 Years	3 years
Time to Progression (TTP)	Up to approximately 3 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to approximately 9 months
Number of Participants with Serious TEAEs	Up to approximately 3 years
Number of Participants with TEAEs Leading to Discontinuation of Treatment	Up to approximately 3 years
Number of Participants with Fatal TEAEs	Up to approximately 3 years
Number of Participants with Treatment-related Adverse Events (AEs)	Up to approximately 9 months
Number of Participants with Adverse Events of Interest (EOI)	Up to approximately 9 months
Serum Concentrations of Tarlatamab	Day 1 up to approximately 6 months
Number of Participants with Antitarlatamab Antibody Formation	Up to approximately 9 months
Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)	Up to approximately 9 months
Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13	Up to 12 months
Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13	Up to 12 months
Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13	Up to 12 months
TTD for Global Health Status as Measured by EORTC-QLQ-C30	Up to approximately 9 months
TTD for Quality of Life as Measured by EORTC-QLQ-C30	Up to approximately 9 months
Overall Response (OR)	Up to approximately 3 years
Disease Control (DC) Rate	Up to approximately 3 years
PFS at 6 Months	6 months
PFS at 1 Year	1 year
Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	Up to approximately 3 years

Trial Locations

Locations (218)

Infirmary Cancer Center; 🇺🇸 Mobile, Alabama, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

University Cancer and Blood Center LLC; 🇺🇸 Athens, Georgia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, United States

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States

Franciscan Health Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

Our Lady of the Lake Cancer Institute; 🇺🇸 Baton Rouge, Louisiana, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

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