RECRUITING

A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC

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 main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).

Official Title

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

Quick Facts

Study Start:2024-12-26
Study Completion:2029-02-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06593522

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 to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
  2. * Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
  3. * Either an archival tissue sample or an archival block must be available.
  4. * Life expectancy of greater than 3 months, in the opinion of the investigator.
  5. * Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
  6. * Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.
  1. * Major surgery within 28 days of study day 1.
  2. * Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

Contacts and Locations

Study Contact

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

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

City of Hope National Medical Center
Duarte, California, 91010
United States
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, 91010
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
United States
Trinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor, Michigan, 48106
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
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 Date2024-12-26
Study Completion Date2029-02-19

Study Record Updates

Study Start Date2024-12-26
Study Completion Date2029-02-19

Terms related to this study

Keywords Provided by Researchers

  • Oncology
  • AMG 193

Additional Relevant MeSH Terms

  • MTAP-deleted NSCLC