LUNAR-2: Study on TTFields with Pembrolizumab and Chemotherapy for Advanced Non-Small Cell Lung Cancer

Sponsor: NovoCure GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06216301

Provider View

This clinical trial is exploring a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) that has spread. The study is testing the combination of TTFields, a device-based therapy, with pembrolizumab and chemotherapy to see if it improves survival and slows disease progression.

Patient Parameters

Program Overview

The LUNAR-2 study is investigating a new treatment method for advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body. This study is testing the use of Tumor Treating Fields (TTFields), delivered by a device called NovoTTF-200T, along with the drug pembrolizumab and platinum-based chemotherapy. The main goals are to see if this combination can help patients live longer and slow down the progression of their cancer. The study will also look at how the treatment works for different types of lung cancer and based on specific cancer markers.

Description

LUNAR-2 is a major study that aims to find out if using Tumor Treating Fields (TTFields) together with pembrolizumab and platinum-based chemotherapy is safe and effective for treating metastatic non-small cell lung cancer (NSCLC). The study will compare the results of patients receiving this combination treatment to those receiving only pembrolizumab and chemotherapy.

The main focus is to see if the combination treatment helps patients live longer and delays the progression of their cancer. Researchers will also analyze how the treatment works for different types of NSCLC and based on the level of a specific protein (PD-L1) in the cancer cells.

Participants will be adults with a good performance status, meaning they are fully active or have some restrictions but can still do light work. The study will include patients from around the world at about 130 locations. The NovoTTF-200T device is a portable system that uses electric fields to disrupt cancer cell division, and it will be used alongside the other treatments.

Eligibility Criteria

Exclusion Criteria

  • Mixed small cell and non-small cell lung cancer.
  • Specific genetic mutations that have approved targeted therapies available.
  • Previous treatment for metastatic disease.
  • Major surgery within 3 weeks before joining the study.
  • Recent radiation therapy to the lung exceeding 30 Gy within 6 months.
  • Recent radiotherapy within 2 weeks before joining the study, unless recovered from side effects and not requiring steroids.
  • Need for other cancer treatments during the study.
  • Another progressing or recently treated cancer within the past 3 years, except for certain skin cancers or carcinoma in situ.
  • Untreated or symptomatic brain metastases, unless treated and stable without steroids.
  • Active autoimmune disease needing treatment in the past 2 years.
  • Immunodeficiency or ongoing steroid/immunosuppressive therapy exceeding 10 mg of prednisone daily.
  • Previous treatment with certain immune therapies within the past year.
  • Participation in another clinical trial within 4 weeks before joining.
  • Concurrent experimental treatments for NSCLC.
  • Allergy to any study drugs.
  • Pregnant or breastfeeding.
  • Institutionalized by administrative or court order.

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