RecruitingPhase 2NCT06731413

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

Sponsor

Virginia Commonwealth University

Enrollment

40 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a reduced-intensity chemotherapy regimen combined with an anti-PD-1 immunotherapy as a first-line treatment for older or frail adults with advanced non-small cell lung cancer (NSCLC) whose tumors have low levels of PD-L1 (less than 50%). **You may be eligible if...** - You have confirmed Stage IIIB, IIIC, or Stage IV non-small cell lung cancer, or recurrent disease - You are 70 or older, or you meet criteria for frailty - You have not received prior treatment for advanced or metastatic disease (earlier chemotherapy finished more than 6 months ago is acceptable) - Your tumor does not have a targetable driver mutation with an approved first-line treatment - Your tumor's PD-L1 score is less than 50% **You may NOT be eligible if...** - You have already received treatment for advanced/metastatic lung cancer - Your tumor has an actionable mutation (e.g., EGFR, ALK) with an approved targeted therapy - Your overall health is very poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGReduced Dose of Chemotherapy and Immunotherapy

Eligible participants with recurrent or metastatic squamous cell carcinoma will receive 4 cycles of carboplatin area under the curve (AUC) 3 IV every 21 days and paclitaxel 135 mg/m2 intravenous (IV) every 21 days. Participants with non-squamous histology will receive carboplatin AUC 3 IV every 21 days and pemetrexed 375 mg/m2 IV every 21 days (collectively, induction chemotherapy). Both groups will receive pembrolizumab 200 mg IV every 21 days for a total of up to 35 cycles (Cycles ≥5 are collectively the maintenance portion of treatment) or until disease progression or unacceptable toxicity.