NCT06731413RecruitingPhase 2
Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
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
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 6 Dec 2024
- Start date
- 11 Feb 2025
- Primary completion date
- 30 Jul 2030
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Lung cancer
- NCT number
- NCT06731413
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 11 Feb 2025 to the primary completion date, 30 Jul 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
Lab values
- Creatinine clearance of \<30 mL/min
Other
- Participants with life expectancy of less than 3 months at the time of enrollment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| VCU Health Tappahannock Hospital Coordinator of this site? Confirm its status | Tappahannock | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.