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Phase 2 Study of Reduced Chemotherapy + Immunotherapy for Advanced NSCLC

This study is for older adults (age 70 and above) with advanced non-small cell lung cancer (NSCLC) that has spread or come back, and has a specific biomarker (PD-L1 less than 50%). You would receive a reduced dose of chemotherapy, including carboplatin and paclitaxel, along with immunotherapy. The main goal is to see how often chemotherapy needs to be stopped because of side effects. You can join if you have NSCLC that is stage IIIB, IIIC, or IV, or if it has returned and cannot be cured by other treatments, and you haven't had previous treatment for advanced disease. The study plans to enroll 40 participants.

Study design
This is a single-arm, open-label Phase 2 study, meaning all 40 participants will receive the same treatment and both you and the study team will know what you are receiving.
What's involved
You will receive 4 cycles of carboplatin and paclitaxel every 21 days. The study will track side effects through the completion of protocol therapy, up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects through the completion of protocol therapy, up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06731413

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Virginia Commonwealth University
~40 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Reduced Dose of Chemotherapy and Immunotherapy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of chemotherapy discontinuation due to treatment-related adverse events
Measured over Through completion of protocol therapy, up to 2 years

Conditions

Non-Small Cell Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer

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Lung Non-Small Cell CarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

2 sites across 1 states
Virginia2

Study leadership

  • Jonathan Berkman, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Massey IIT Research Operations
[email protected]
804-628-6430
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Occurrence of chemotherapy discontinuation due to treatment-related adverse eventsThrough completion of protocol therapy, up to 2 years

    Evaluate treatment tolerability i by the number of participants that discontinue chemotherapy treatment due to treatment-related adverse events.