RECRUITING

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

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Conditions

Limited Stage Small Cell Lung CancerSmall Cell Lung CancerLS SCLCSCLCAMG 757Tarlatamab

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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 compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Quick Facts

Study Start:2024-02-20
Study Completion:2030-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06117774

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. * Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  2. * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  3. * Histologically or cytologically confirmed small-cell lung cancer (SCLC).
  4. * Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
  5. * Has completed chemoradiotherapy without progression per RECIST 1.1 (ie, achieved complete response \[CR\], partial response \[PR\], or stable disease \[SD\]).
  6. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  7. * Minimum life expectancy of 12 weeks.
  8. * Adequate organ function.
  9. * Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.
  1. * Extensive-stage SCLC (ES-SCLC).
  2. * Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
  3. * Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
  4. * History of other malignancy within the past 2 years, with certain exceptions.
  5. * History of solid organ transplantation.
  6. * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
  7. * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
  8. * Exclusion of human immunodeficiency virus (HIV) or active hepatitis infection based on criteria per protocol.
  9. * Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
  10. * Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic radiotherapy with chemotherapy) during chemoradiation.
  11. * Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
  12. * Prior history of severe or life-threatening events from any immune-mediated therapy.
  13. * Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
  14. * Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
  15. * Major surgical procedures within 28 days prior to first dose of study treatment.
  16. * Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.
  17. * Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of study treatment.
  18. * Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.
  19. * Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
  20. * Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
  21. * Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of study treatment.
  22. * Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment.
  23. * Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.
  24. * Participant has known sensitivity to any of the products or components to be administered during dosing.
  25. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
  26. * History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

Contacts and Locations

Study Contact

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

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
University of California Los Angeles
Santa Monica, California, 90404
United States
Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
Boca Raton Clinical Research Global South Florida
Plantation, Florida, 33322
United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202
United States
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, 70808
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, 10016
United States
Perlmutter Cancer Center at New York University Langone Hospital - Long Island
New York, New York, 10016
United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461
United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States
Spokenword Clinical Trials
Easton, Pennsylvania, 18045
United States
Renovatio Clinical
The Woodlands, Texas, 77380
United States
US Oncology Research Investigational Products Center
The Woodlands, Texas, 77380
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, 26506
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 Date2024-02-20
Study Completion Date2030-03-31

Study Record Updates

Study Start Date2024-02-20
Study Completion Date2030-03-31

Terms related to this study

Keywords Provided by Researchers

  • Limited Stage Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • LS SCLC
  • SCLC
  • AMG 757
  • Tarlatamab

Additional Relevant MeSH Terms

  • Limited Stage Small Cell Lung Cancer
  • Small Cell Lung Cancer