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Using Tumor Treating Fields with Pembrolizumab for Advanced Lung Cancer

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

Phase 2 Interventional NovoCure Ltd. · NCT06558799

This study is testing if a new treatment combining Tumor Treating Fields with pembrolizumab can help people with advanced lung cancer who haven't responded well to previous therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment69 (estimated)
Ages18 Years and up
SexAll
SponsorNovoCure Ltd. Industry-sponsored
Drugs / interventionspembrolizumab, chemotherapy
Locations19 sites (Salzburg and 18 other locations)
Trial IDNCT06558799 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of Tumor Treating Fields (TTFields) therapy, delivered through the NovoTTF-200T device, in combination with pembrolizumab for patients with metastatic non-small cell lung cancer (NSCLC). Participants must have previously received treatment with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy. The study will assess how well this combination works in patients who have shown disease progression after their initial treatments. The goal is to determine if this novel approach can improve outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic NSCLC who have previously received specific treatments and show positive tumor PD-L1 expression.

Not a fit: Patients who have not received prior PD-1/PD-L1 inhibitor therapy or those with certain exclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced NSCLC who have limited treatment choices.

How similar studies have performed: While the combination of TTFields and immunotherapy is a novel approach, similar studies have shown promise in enhancing treatment efficacy for various cancers.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 exclusion criteria will be excluded from study participation:

* Mixed small cell and NSCLC histology.
* Subject must not have leptomeningeal disease or spinal cord compression.
* Subject must not have untreated, symptomatic brain metastases, or residual neurological dysfunction.
* Subjects must not have received more than one line of PD-1/PD-L1 inhibitor for advanced disease.
* Subjects with a known sensitizing mutation for which the Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1) are excluded unless previously received at least one of the approved therapy(ies).
* Subjects with more than 2 lines of therapy in the advanced setting.
* Pregnant or breastfeeding.
* Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso.
* Known allergies to medical adhesives or hydrogel.

Where this trial is running

Salzburg and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerNSCLCMetastatic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.