Actively Recruiting
Phase 2 Study to Evaluate Reduced Dose Chemotherapy Combined With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults With Advanced PD-L1 TPS <50% Non-Small Cell Lung Cancer
Led by Virginia Commonwealth University · Updated on 2026-06-02
40
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying vulnerable or older adults aged 70 and above with recurrent or metastatic non-small cell lung cancer (NSCLC) that has a PD-L1 tumor proportion score (TPS) less than 50%. The study aims to evaluate how often treatment-related side effects cause patients to stop chemotherapy when receiving a reduced dose of chemotherapy combined with immunotherapy. This is a phase 2, single-arm, open-label study assessing safety and tolerability in this specific patient group. Participants with squamous cell NSCLC will receive carboplatin and paclitaxel chemotherapy every 21 days for 4 cycles, while those with non-squamous NSCLC will receive carboplatin and pemetrexed on the same schedule. Both groups will receive pembrolizumab immunotherapy every 21 days for up to 35 cycles or until disease progression or unacceptable side effects occur. The first 4 cycles include chemotherapy plus immunotherapy, followed by maintenance immunotherapy alone from cycle 5 onward. During the study, participants will be closely monitored for treatment side effects, response to therapy, survival outcomes, and quality of life at multiple time points up to several years. Researchers will collect data on adverse events, disease progression, and cancer symptoms through scans, lab tests, and questionnaires. The primary outcome is the rate of chemotherapy discontinuation due to side effects over up to two years of treatment. Secondary outcomes include response rates, overall survival, progression-free survival, and symptom changes up to five years.
CONDITIONS
Brief Title
Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non-squamous)
- Stage IIIB, IIIC, or IV disease or recurrent disease not eligible for curative treatment
- No previous treatment for recurrent or metastatic disease; prior neoadjuvant or adjuvant treatment allowed if completed more than 6 months before enrollment
- Age 70 or older or meeting frailty definition at consent
- No driver mutations with FDA-approved targeted therapy available
- PD-L1 tumor proportion score less than 50%
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- Measurable disease per RECIST 1.1
- Absolute neutrophil count at least 1,000/µL
- Platelets at least 75,000/µL
- Hemoglobin at least 8.0 g/dL (transfusion allowed)
- Total bilirubin less than or equal to 2 times institutional upper limit of normal
- AST/ALT less than or equal to 5 times institutional upper limit of normal
- Ability and willingness to sign informed consent
You will not qualify if you...
- Life expectancy less than 3 months at enrollment
- Active autoimmune disease requiring systemic treatment in past 2 years
- Diagnosis of interstitial lung disease
- Creatinine clearance less than 30 mL/min
- Symptomatic, untreated central nervous system disease or leptomeningeal disease; asymptomatic or treated CNS disease allowed
- Ongoing use of immunosuppressive medication except low-dose steroids (prednisone ≤10 mg daily), short steroid courses stopped before enrollment, or inhaled/topical steroids
- Dexamethasone taper for CNS edema allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or unacceptable toxicity
Participants receive reduced dose chemotherapy combined with anti-PD-1 immunotherapy. Chemotherapy is given every 21 days for 4 cycles, while immunotherapy is administered every 21 days for up to 35 cycles or until disease progression or unacceptable toxicity.
Every 3 weeks for up to 35 cycles
Duration - Up to 3 years following treatment
Participants are monitored for response, adverse events, overall survival, progression-free survival, and quality of life after treatment completion.
Periodic visits up to 5 years post-treatment
Trial Site Locations
Total: 2 locations
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
2
VCU Health Tappahannock Hospital
Tappahannock, Virginia, United States, 22560
Actively Recruiting
Research Team
M
Massey IIT Research Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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