Georgia's Online Cancer Information Center

Find A Clinical Trial

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03319940
Protocol IDs
20160323 (primary)
NCI-2017-02043
Study Sponsor
Amgen, Inc.

Summary

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Objectives

This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab
monotherapy, in combination with anti-PD1 therapy and with additional cytokine release
syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term
intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE)
Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Eligibility

  1. Participant has provided informed consent prior to initiation of any study-specific activities/procedures
  2. Age greater than or equal to 18 years old at the time of signing the informed consent
  3. Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  5. Participants with treated brain metastases are eligible provided they meet defined criteria
  6. Adequate organ function as defined in protocol

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.