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

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Jonathan Berkman, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2033-07-30