LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

Conditions

• Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NovoTTF-200T — DEVICE
  The NovoTTF-200T is a portable, battery operated system intended for continuous home use, which delivers TTFields at a frequency of 150kHz to the subject by means of insulated transducer arrays. TTFields physically disrupt the rapid cell division exhibited by cancer cells. The physical disruption induced by TTFields can lead to to downstream immunogenic cell death.
• Pembrolizumab — DRUG
  Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
• Platinum based chemotherapy — DRUG
  Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer

Study Details

This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer.

Key Dates

Start date

Jul 31, 2024

Status verified

Dec 2025

Primary completion

Oct 31, 2028

Completion

Oct 31, 2028

Study Design

Enrollment

734 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy
  Subjects in this arm receive three treatments - TTFields using the NovoTTF-200T device, pembrolizumab, and platinum-based chemotherapy.
• Active Comparator: Arm 2: Pembrolizumab and Platinum-based Chemotherapy
  Subjects in this arm receive two treatments - pembrolizumab and platinum-based chemotherapy.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: up to 6 years ]

Locations (35)

Find similar trials in Birmingham, AL

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