RecruitingPhase 1NCT04297605

Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2

A Pilot Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2


Sponsor

University of Rochester

Enrollment

60 participants

Start Date

May 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an immunotherapy drug (pembrolizumab) and a single chemotherapy drug as a first treatment option for people with advanced lung cancer who are too frail for aggressive standard chemotherapy. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with non-small cell lung cancer (NSCLC) - Your cancer is at an advanced stage (IIIc or IV) - You have a moderate level of physical limitation (ECOG performance status 2 — meaning you can care for yourself but cannot do physical work) - Standard aggressive chemotherapy is not an option for you or you have declined it - Your blood counts, kidney, and liver function meet minimum requirements **You may NOT be eligible if...** - You have active autoimmune disease (some exceptions apply) - You are on significant doses of immune-suppressing medications like steroids - You have serious heart, liver, or kidney disease - You are pregnant or breastfeeding - You are currently enrolled in another clinical trial 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

DRUGPembrolizumab

Pembrolizumab 200 mg

OTHERPemetrexed (Chemotherapy)

500 mg/m2 day 1 of 21 day cycle (for non-squamous only)

OTHERNab-paclitaxel (Chemotherapy)

100 mg/m2 days 1,8 of 21 day cycle x 4 cycles


Locations(2)

University of Rochester

Rochester, New York, United States

University of Rochester

Rochester, New York, United States

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NCT04297605


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