Reduced chemotherapy and immunotherapy for older adults with advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of a reduced dose of chemotherapy combined with immunotherapy in older adults aged 70 and above who have advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score of less than 50%. It is a single-arm, open-label phase 2 trial focusing on patients who are not candidates for curative treatment and have not received prior treatment in the recurrent or metastatic setting. The primary goal is to assess the frequency of adverse events leading to chemotherapy discontinuation in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
* Stage IIIB, IIIC or 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 (biomarker testing is optional for squamous cell)
* 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

Where it's running

• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting
• VCU Health Tappahannock Hospital
  Tappahannock, Virginia, United States Recruiting

Study contacts

• Principal investigator: Jonathan Berkman, MD — Virginia Commonwealth University
• Study coordinator: Massey IIT Research Operations
• Email: masseyepd@vcu.edu
• Phone: 804-628-6430

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.