Non-Small Cell Lung Cancer (NSCLC)Phase 2LUNAR-4NCT06558799
LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study testing NovoTTF-200T and Pembrolizumab in people with Non-Small Cell Lung Cancer (NSCLC), run by NovoCure GmbH at 24 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- NovoTTF-200T and Pembrolizumab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 14 Oct 2024to 23 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
France7 sites
APHP - Hôpital Ambroise-Paré
Boulogne-Billancourt, 92100
Centre hospitalier intercommunal de Créteil Service de Pneumologie
Créteil, 94010
Centre Léon Berard Service D'oncologie Médicale
Lyon, 69373
Hôpital Européen Marseille
Marseille, 13003
Montpellier University Hospital
Montpellier, 34295
Hôpital Privé du Confluent Service D'oncologie Médicale
Nantes, 44277
Centre Hospitalier Intercommunal de Cornouaille Service D'oncologie Médicale
Quimper, 29107
Spain6 sites
Hospital Universitario del Vinalopó
Elche, 03293
Hospital Universitario Arnau de Vilanova
Lleida
Clínica Universidad de Navarra, Madrid
Madrid, 28027
Hospital Regional Universitario de Malaga (Hospital Civil)
Málaga
Clínica Universidad de Navarra
Pamplona, 31008
Hospital Universitario Virgen del Rocio
Seville
Italy4 sites
Humanitas Gavazzeni Bergamo-U.O.Farmacia-Edificio D Piano -1
Bergamo
Istituto Europeo di Oncologia
Milan, 20141
AO SM Misericordia di Perugia
Perugia, 06129
AOUS Policlinico Le Scotte U.O.C. Immunoterapia Oncologica
Siena, 53100
Czechia3 sites
Vitkovicka Nemocnice
Ostrava, 1192
General University Hospital in Prague, Clinic of Oncology
Prague, 128 08
FN Motol
Prague, 150 06
Poland2 sites
Pratia MCM Kraków
Krakow
MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spó?ka Jawna
Lublin
About this study
Official title: 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
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.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- NovoTTF-200T, Pembrolizumab
- Keywords
- NSCLC, Metastatic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-200TDevice
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.
PembrolizumabDrug
Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| NovoTTF-200T + Pembrolizumab | Experimental | Not described Receives: Device: NovoTTF-200T; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
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)
Measured: 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start14 Oct 2024
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Why it stopped: EF-50/LUNAR-4 was terminated because available real-world data are expected to enable Novocure to achieve the study objectives without an interventional clinical study. Termination was not due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoCure GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558799
- Sponsor's protocol ID
- EF-50
- Acronym
- LUNAR-4
- Status last verified
- Oct 2025
- First submitted
- 31 Jul 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06558799
- Acronym / sponsor ID
- LUNAR-4 / EF-50
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Keywords
- NSCLC, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: EF-50/LUNAR-4 was terminated because available real-world data are expected to enable Novocure to achieve the study objectives without an interventional clinical study. Termination was not due to safety concerns.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NovoCure GmbHIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoTTF-200T + Pembrolizumab | Experimental | Device: NovoTTF-200T, Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- ≥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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoTTF-200TThe 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. | Device | NovoTTF-200T + Pembrolizumab |
| PembrolizumabPembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. | Drug | NovoTTF-200T + Pembrolizumab |
Primary outcome
Overall Survival
Time frame: 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)
Results and safety
The study was stopped early (reason given: EF-50/LUNAR-4 was terminated because available real-world data are expected to enable Novocure to achieve the study objectives without an interventional clinical study. Termination was not due to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NovoTTF-200T and Pembrolizumab in people with Non-Small Cell Lung Cancer (NSCLC), run by NovoCure GmbH at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, Spain, Italy, Czechia, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: EF-50/LUNAR-4 was terminated because available real-world data are expected to enable Novocure to achieve the study objectives without an interventional clinical study. Termination was not due to safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.