RECRUITING

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

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Conditions

Extensive Stage Small Cell Lung CancerSmall Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Official Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Quick Facts

Study Start:2024-10-07
Study Completion:2028-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06598306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
  2. * Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based regimen.
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  4. * Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
  5. * Participants must be able to have SC injections administered in the abdomen (and/or thigh).
  6. * Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.
  1. * Participants that have received prior DLL3 targeted therapy.
  2. * Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
  3. * Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
  4. * Participants with leptomeningeal disease.
  5. * Participants with baseline oxygen requirement.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-07
Study Completion Date2028-05-01

Study Record Updates

Study Start Date2024-10-07
Study Completion Date2028-05-01

Terms related to this study

Keywords Provided by Researchers

  • Small Cell Lung Cancer

Additional Relevant MeSH Terms

  • Extensive Stage Small Cell Lung Cancer