LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)

LUNAR-4: Pilot, Single Arm, Open-Label, Multinational Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for the Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a PD-1/PD-L1 Inhibitor and Platinum-Based Chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06558799

Acronym

LUNAR-4

Enrollment

Registered

2024-08-19

Start date

2024-10-14

Completion date

2026-01-31

Last updated

2025-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Keywords

NSCLC, Metastatic

Brief summary

The purpose of the study is to test the effectiveness and safety of TTFields therapy, delivered using the NovoTTF-200T device, concomitant with pembrolizumab in subjects with metastatic NSCLC previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.

Interventions

DEVICENovoTTF-200T

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 exert electric forces intended to disrupt cancer cell division and induce immunogenic cell death.

DRUGPembrolizumab

Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥18 years of age * Histologically or cytologically confirmed diagnosis of NSCLC. * Documented positive tumor PD-L1 expression (TPS≥1%). * Eastern Cooperative Oncology Group (ECOG) Score of 0-1. * Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease. * Subjects must have received one line of PD-1/PD-L1 inhibitor therapy for advanced or metastatic NSCLC. PD-1/PD-L1 inhibitor may have been given alone or in combination with other therapy. * Subjects who received PD-1/PD-L1 inhibitor for advanced disease, must have had a best response on PD-1/PD-L1 inhibitor of stable disease (SD), partial response (PR) or complete response (CR). * Subjects must have experienced disease progression more than 84 days following Cycle 1 Day 1 (C1D1) of their most recent PD-1/PD-L1 inhibitor therapy.

Exclusion criteria

- All individuals meeting any of the following

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival	16	To compare OS in subjects treated with TTFields concomitant with pembrolizumab compared to OS of subjects who were treated with docetaxel alone in the LUNAR/ EF-24 study (superiority analysis)

Countries

Austria, Czechia, France, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026