A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

Phase 3

Not yet recruiting

• Conditions: Small-cell Lung Cancer; Extensive Stage Small-cell Lung Cancer
• Interventions: Drug: Tarlatamab; Drug: Durvalumab; Drug: Carboplatin; Drug: Etoposide

• Registration Number: NCT07005128
• Lead Sponsor: Amgen

Brief Summary

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Study Start: 2025-06-20
• Primary Completion: 2028-12-20
• Study Completion: 2029-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Participant has provided informed consent before initiation of any study-specific activities/procedures.
• Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
• Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
• Measurable disease as defined per RECIST 1.1.
• Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
• Minimum life expectancy ≥ 12 weeks.

Exclusion Criteria

• Participants can have no history of other malignancy in the last 2 years.
• Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
• Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
• They will have no history of severe or life-threatening events to immune-mediated therapy.
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
• They will have no active autoimmune or inflammatory disorders.
• Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
• Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
• History of solid organ transplant.
• They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tarlatamab + Durvalumab + Carboplatin + Etoposide	Tarlatamab	Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
Tarlatamab + Durvalumab + Carboplatin + Etoposide	Durvalumab	Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
Tarlatamab + Durvalumab + Carboplatin + Etoposide	Carboplatin	Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
Tarlatamab + Durvalumab + Carboplatin + Etoposide	Etoposide	Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
Durvalumab + Carboplatin + Etoposide	Durvalumab	Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
Durvalumab + Carboplatin + Etoposide	Carboplatin	Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
Durvalumab + Carboplatin + Etoposide	Etoposide	Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 3.5 years

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Up to approximately 4 years
Objective Response (OR)	Up to approximately 4 years
Disease Control	Up to approximately 4 years
Duration of Response (DOR)	Up to approximately 4 years
PFS Rate	6 months, 1 year, and 2 years
OS Rate	6 months, 1 year, and 2 years
Time to Progression	Up to approximately 4 years
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)	Up to approximately 4 years
Number of Participants Who Experience Treatment-related Adverse Events	Up to approximately 4 years
Number of Participants Who Experience Events of Interest	Up to approximately 4 years
Serum Concentrations of Tarlatamab	Up to approximately 1 year
Number of Participant Who Develop Anti-Tarlatamab Antibodies	Up to 13 months