Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)

NCT07778316 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20250046
• Study Type: interventional
• Target: 400
• Locations: 5 countries
• Sites: 9

Brief Summary

The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.

Conditions

Small Cell Lung Cancer

Keywords

Tarlatamab; ES-SCLC

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab

  From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)

• Predose Concentration (Ctrough) of Tarlatamab

  On Cycle 2 Day 15 (each cycle is 28 days)

Secondary Outcomes (11)

• Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

  Up to approximately 4 years

• Progression free survival (PFS) per RECIST v1.1

  Up to approximately 4 years

• Duration of response (DOR) per RECIST v1.1

  Up to approximately 4 years

• Disease control (DC) per RECIST v1.1

  Up to approximately 4 years

• Overall survival (OS)

  Up to approximately 4 years

Study Arms (2)

Tarlatamab SC

EXPERIMENTAL

Participants will receive Tarlatamab via SC injection

Drug: Tarlatamab

Tarlatamab IV

ACTIVE COMPARATOR

Participants will receive Tarlatamab via IV infusion

Drug: Tarlatamab

Interventions

Tarlatamab DRUG

Administered via SC injection or IV infusion

Also known as: AMG 757, IMDELLTRA

Tarlatamab IV; Tarlatamab SC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
• Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
• Participants who progressed or recurred following 1 platinum-based regimen.
• Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate organ function.
• History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.

You may not qualify if:

• Disease Related
• \- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.
• Other Medical Conditions
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
• History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
• Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.
• History of other malignancy within the past 2 years, with exceptions defined in the protocol.
• Presence or history of viral infection based on criteria per protocol.
• History of solid organ transplantation.
• Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
• Known sensitivity or a contraindication to any of the products or components.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• Prior/Concomitant Therapy
• Prior systemic anticancer therapy within 30 days of enrolment
• Prior history of severe or life-threatening events from any immune-mediated therapy.

Sponsors & Collaborators

• Amgen: lead

Study Sites (9)

University of Florida Health Cancer Center at Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503, United States

RECRUITING

Oncology Hematology West PC

Omaha, Nebraska, 68130, United States

RECRUITING

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, 200433, China

RECRUITING

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

RECRUITING

Universitaetsspital Zuerich

Zurich, 8091, Switzerland

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

AMG 757

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 21, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): July 30, 2030
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

CN (3); US (3); AU (1); JP (1); CH (1)