Study on Pembrolizumab Every 12 Weeks Versus Every 3 Weeks for Treating Non-small Cell Lung Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT04032418

Provider View

This clinical trial is comparing two different schedules for giving pembrolizumab, an immunotherapy drug, to patients with non-small cell lung cancer. The study aims to see if receiving the drug every 12 weeks is as effective as every 3 weeks, potentially offering similar benefits with fewer treatments.

Patient Parameters

Program Overview

This study is exploring whether giving the immunotherapy drug pembrolizumab every 12 weeks can control non-small cell lung cancer as effectively as giving it every 3 weeks. Pembrolizumab helps the immune system attack cancer cells and may prevent them from growing and spreading. If the 12-week schedule works as well as the 3-week schedule, it could mean fewer treatments and lower costs for patients.

Description

The main goal of this study is to compare the effectiveness of pembrolizumab given every 3 weeks versus every 12 weeks in keeping cancer from progressing over one year. Researchers will also look at overall survival rates and any serious side effects between the two groups. Additionally, the study will explore biological markers in the blood and gut that might indicate how well the treatment is working.

Participants will be randomly assigned to one of two groups:

  • Group 1: Receive pembrolizumab through an IV every 3 weeks for up to 24 months, unless the cancer progresses or side effects become too severe.
  • Group 2: Receive pembrolizumab through an IV every 12 weeks for up to 24 months, unless the cancer progresses or side effects become too severe.

After finishing the treatment, participants will have follow-up visits 30 days later and then every 12 weeks for at least a year.

Eligibility Criteria

Inclusion Criteria

  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Diagnosed with non-small cell lung cancer (NSCLC), not mixed with small cell lung cancer.
  • Eligible for pembrolizumab treatment as part of standard care.
  • Meet specific blood count and organ function requirements.
  • Have shown a positive response or stable disease with pembrolizumab before joining the study.
  • Have received pembrolizumab for at least 6 months but not more than 15 months before starting the study treatment.
  • Agree to use effective birth control methods if of childbearing potential.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have received other cancer treatments besides pembrolizumab in the last 6 months.
  • Have cancer that has progressed while on pembrolizumab.
  • Have had recent radiation therapy or surgery that has not fully healed.
  • Have active or untreated brain metastases.
  • Have a tumor with a mutation sensitive to targeted therapy.
  • Have had pembrolizumab treatment interrupted for more than 4 weeks due to side effects.
  • Are currently on high-dose steroids or have not recovered from recent steroid use.
  • Have had major surgery within the last 14 days.
  • Have serious infections or uncontrolled medical conditions.
  • Are pregnant or breastfeeding.
  • Are unable or unwilling to follow the study requirements.

Locations

FACILITYZIPCITYSTATE
Roswell Park Cancer Institute14263BuffaloNew York

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