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

Last updated: February 21, 2025
Sponsor: Virginia Commonwealth University
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

Reduced Dose of Chemotherapy and Immunotherapy

Clinical Study ID

NCT06731413
MCC-24-21788
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 curativetreatment such as combined chemo-radiation

  • No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant oradjuvant treatment more than 6 months before enrollment is acceptable.

  • Age 70 or meeting frailty definition or above at the date of signing informedconsent

  • 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 siteinvestigator/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 consentdocument

Exclusion

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 leptomeningealdisease. Patients with asymptomatic or treated CNS disease are eligible

  • Required ongoing use of immunosuppressive medication, including steroids, with thefollowing 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

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Reduced Dose of Chemotherapy and Immunotherapy
Phase: 2
Study Start date:
February 11, 2025
Estimated Completion Date:
July 30, 2033

Study 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.

Connect with a study center

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

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