Reduced chemotherapy and immunotherapy for older adults with advanced lung cancer
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
This study is testing a lower dose of chemotherapy combined with immunotherapy to see if it's safe and tolerable for older adults over 70 with advanced lung cancer who can’t have curative treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | radiation, prednisone, chemotherapy, immunotherapy |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06731413 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 70 or above with advanced non-small cell lung cancer and a PD-L1 TPS of less than 50%.
Not a fit: Patients with driver mutations that have FDA-approved targeted therapies or those with a PD-L1 TPS of 50% or greater may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer treatment option for older adults with advanced lung cancer, potentially improving their quality of life and treatment adherence.
How similar studies have performed: While there have been studies on chemotherapy and immunotherapy in lung cancer, this specific approach targeting vulnerable older adults with reduced dosing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.