RECRUITING

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

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Conditions

Non-Small Cell Lung CancerNSCLCAdvanced Non-Small Cell Lung CancerMetastatic Non Small Cell Lung CancerNon-Small Cell Lung Cancer, NSCLC

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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

Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS\<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.

Official Title

Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer

Quick Facts

Study Start:2025-02-11
Study Completion:2033-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06731413

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. * Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
  2. * Stage IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
  3. * No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
  4. * Age 70 or meeting frailty definition or above at the date of signing informed consent
  5. * Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy
  6. * PD-L1 tumor proportion score (TPS) of less than 50%
  7. * Eastern Cooperative Oncology Group (ECOG) PS of 0-3
  8. * Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment
  9. * Absolute neutrophil count (ANC) ≥ 1,000/μL
  10. * Platelets ≥ 75,000/μL
  11. * Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion permitted)
  12. * Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
  13. * Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN
  14. * Ability to understand and the willingness to sign a written informed consent document
  1. * Participants with life expectancy of less than 3 months at the time of enrollment
  2. * Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
  3. * Diagnosis of interstitial lung disease
  4. * Creatinine clearance of \<30 mL/min
  5. * Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
  6. * Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:
  7. * Doses less than or equal to the equivalent of prednisone 10 mg daily
  8. * Short courses of steroids that are discontinued prior to enrollment
  9. * Inhaled, intranasal and/or topical steroids
  10. * Dexamethasone taper for treating vasogenic edema associated with CNS disease

Contacts and Locations

Study Contact

Massey Lung Team
CONTACT
804-628-6430
masseylung@vcu.edu
Carrie Donovan, RN
CONTACT
804-628-3836
cdonovan2@vcu.edu

Principal Investigator

Jonathan Berkman, MD
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Jonathan Berkman, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

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 Date2025-02-11
Study Completion Date2033-07-30

Study Record Updates

Study Start Date2025-02-11
Study Completion Date2033-07-30

Terms related to this study

Keywords Provided by Researchers

  • Non-Small Cell Lung Cancer, NSCLC

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Advanced Non-Small Cell Lung Cancer
  • Metastatic Non Small Cell Lung Cancer