A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer

• Conditions: kleincellig longkanker; extensive stage small cell lung cancer; lung cancer; 10029107

• Registration Number: NL-OMON53561
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

• Participant has provided informed consent/assent prior to initiation of any
study specific activities/procedures
• Age greater than or equal to 18 years old at the same time of signing the
informed consent
• Participants with histologically or cytologically confirmed Extended Stage
Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC
other than protocol defined standard of care first line therapy prior to
enrollment. Subjects with prior treatment for limited stage SCLC (LS-SCLC) are
permitted.
• Eastern Cooperative Oncology Group (ECOG) 0 to 1
• Participants with treated asymptomatic brain metastases are eligible provided
they meet defined criteria
• Adequate organ function as defined in protocol

Please refer to section 5.1 of the protocol for the full list of inclusion
criteria and any changes in these following protocol amendment 3.

Exclusion Criteria

• History of other malignancy within the past 2 years with exceptions
• Major surgery within 28 days of study day 1
• Untreated or symptomatic brain metastases and leptomeningeal disease

Please refer to section 5.2 of the protocol for the full list of exclusion
criteria and any changes in these following protocol amendment 3.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dose-limiting toxicities (DLTs), treatment-emergent and treatment-related<br /><br>adverse events, changes in vital signs, electrocardiograms (ECGs), and clinical<br /><br>laboratory tests.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Progression free survival, will be based on modified Response Evaluation<br /><br>Criteria in Solid Tumors version 1.1 (RECIST v1.1).<br /><br>- Objective response, based on modified RECIST v1.1<br /><br>- Duration Of Response, and Disease control, as per modified RECIST v1.1.<br /><br>- Overall survival (OS) as per modified RECIST v1.1<br /><br>- Serum concentrations of tarlatamab.</p><br>