Study on Tumor Treating Fields and Pembrolizumab for First-Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor: NovoCure GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04892472

Provider View

This clinical trial is testing a new treatment approach using Tumor Treating Fields (TTFields) along with the drug pembrolizumab for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. The study aims to see if this combination can help control the cancer better than pembrolizumab alone.

Patient Parameters

Program Overview

This study is exploring a new treatment method for advanced or metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. It involves using Tumor Treating Fields (TTFields), a portable device that delivers electric fields to the tumor area, along with the drug pembrolizumab. The main goal is to see if this combination can help patients live longer without their cancer getting worse, compared to using pembrolizumab alone. The study will include 100 patients who have not received previous treatments for their advanced cancer and will last about two years.

Description

This clinical trial is investigating a new treatment for advanced or metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. The treatment combines Tumor Treating Fields (TTFields), a device that uses electric fields to target cancer cells, with pembrolizumab, a drug that helps the immune system fight cancer.

The study will enroll 100 patients who have not received previous treatments for their advanced cancer. Participants will be randomly assigned to receive either the combination of TTFields and pembrolizumab or pembrolizumab alone. The TTFields device is portable and will be used for about 18 hours a day, while pembrolizumab will be given through an IV every three weeks.

The study will last approximately two years, and participants will be monitored for how long they live without their cancer getting worse. The treatment will continue for up to 24 months or until certain conditions occur, such as disease progression or unacceptable side effects. If a participant starts another cancer treatment, they will be removed from the study.

Participants who stop the study treatment before their cancer progresses will be followed up monthly by phone to check on their health status until the end of the study or other specified conditions occur.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage III or metastatic non-small cell lung cancer (NSCLC) without specific genetic mutations (EGFR or ALK).
  • Age 22 years or older.
  • Tumor is PD-L1 positive (TPS≥1%).
  • Have cancer that can be measured in the chest area.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Have not received previous treatments for advanced NSCLC, except for certain types of treatment given more than 12 months ago.
  • Life expectancy of at least 3 months.
  • Able to use the TTFields device.

Exclusion Criteria

  • Have active or untreated cancer spread to the brain or spinal cord.
  • Have specific genetic mutations (EGFR or ALK) that can be treated with other therapies.
  • Can be treated with surgery or chemoradiation with the intent to cure.
  • Have received certain immune therapies in the past 12 months.
  • Have received previous systemic cancer treatment for advanced NSCLC.
  • Unable to use the TTFields device independently or with help.
  • Pregnant or breastfeeding.
  • Received a live vaccine in the past 30 days or had major surgery in the last 3 weeks.
  • Expected to need other cancer treatments while in the study.

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