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

Sponsor: Virginia Commonwealth University

Sponsor score: 0

ClinicalTrials ID:NCT06731413

This phase 2 study assesses safety and tolerability of reduced chemotherapy and immunotherapy in vulnerable adults (≥70) with recurrent/metastatic NSCLC, PD-L1 TPS <50%. Eligibility includes confirmed NSCLC, stage IV or recurrent disease, no prior metastatic treatment, and specific lab criteria. Participants receive carboplatin, paclitaxel/pemetrexed, and pembrolizumab.

Patient Parameters

Program 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.

Description

This is a single institution, single arm, open label phase 2 study in vulnerable or older adults (Age ≥70) with recurrent or metastatic, histologically confirmed squamous cell carcinoma or non-squamous cell carcinoma of lung without driver mutation and PD-L1 TPS < 50% to evaluate safety and tolerability of reduced dose of chemotherapy and immunotherapy.

Eligibility Criteria

Inclusion 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

Exclusion Criteria

  • 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

Locations

FACILITYZIPCITYSTATE
Virginia Commonwealth University23298RichmondVirginia

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