RecruitingRecruiting
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
NCT06216301 · NovoCure Ltd.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer
About this study
LUNAR-2 is a pivotal, randomized, open-label study that aims to evaluate the effectiveness and safety of Tumor Treating Fields (TTFields) concomitantly administered with pembrolizumab and platinum-based chemotherapy for the treatment of metastatic non-small cell lung cancer (NSCLC).
The primary objectives of the study are to assess overall survival (OS) and progression-free survival (PFS) in subjects treated with TTFields, pembrolizumab, and platinum-based chemotherapy compared to those treated with pembrolizumab and platinum-based chemotherapy alone. PFS will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
The secondary endpoints of this study will evaluate PFS and OS, stratified by the specific histological subtype of NSCLC and PD-L1 Tumor Proportion Score (TPS).
The population will consist of subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and will be stratified as follow:
1. Histology - Squamous vs. non-squamous
2. PD-L1 expression level - TPS \<1% vs. 1% ≤TPS \<50% vs. TPS ≥50%
3. Prior treatment with immunotherapy - yes vs. no
The study will be conducted globally at approximately 130 participating sites. The study device, NovoTTF-200T, is a portable, battery-operated system that delivers TTFields at a frequency of 150kHz. It utilizes insulated transducer arrays to deliver electric forces intended to disrupt cancer cell division.
Eligibility criteria
Inclusion Criteria
* ≥22 years of age in the USA
≥18 years of age outside of the USA.
* Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer \[AJCC\] criteria) non-squamous or squamous NSCLC.
* Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1.
* Have not received prior systemic treatment for their metastatic NSCLC. Subjects who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if the therapy was completed at least 12 months prior to the development of metastatic disease.
* ECOG Performance Status (PS) of 0-1.
* Adequate hematologic and end-organ function
o For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants).
* A female participant is eligible to participate if she is not pregnant, not breastfeeding
* If male subject with a female partner(s) of child-bearing potential, must agree to use an effective contraception
* All subjects must sign written informed consent.
Exclusion Criteria:
All individuals meeting any of the following exclusion criteria will be excluded from study participation:
* Mixed small cell and NSCLC histology.
* EGFR sensitizing mutation and/or ALK translocation, and/or ROS1 and/or RET targetable gene rearrangement, and/or METex14 skipping mutation, and/or NTRK1/2 gene fusion and/or BRAF V600 mutations directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available.
* Has received systemic therapy for metastatic disease.
* Had major surgery \<3 weeks prior to randomization
* Received radiation therapy to the lung that is \> 30 Gy within 6 months of randomization.
* Has received prior radiotherapy within 2 weeks of randomization. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
* Is expected to require any other form of antineoplastic therapy while on study.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
* Has symptomatic Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Subjects with asymptomatic CNS metastases or with previously treated brain metastases may participate provided they were treated before randomization (if applicable) and are neurologically stable and without requirement of steroid treatment for at least 7 days prior to randomization.
* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior randomization. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
* Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms in the 12 months prior to randomization.
* Participation in another clinical study with an investigational agent or device during the 4 weeks prior to randomization.
* Concurrent treatment with other experimental treatments for NSCLC while in the study.
* Has a known sensitivity to any component of the planned systemic therapies (pembrolizumab, cisplatin/carboplatin, pemetrexed/paclitaxel/nab-paclitaxel) .
* Pregnant or breastfeeding
* Admitted to an institution by administrative or court order.
Study design
Enrollment target: 734 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-31
Estimated completion: 2028-10
Last updated: 2026-06-25
Interventions
Device: NovoTTF-200TDrug: PembrolizumabDrug: Platinum based chemotherapy
Primary outcomes
- • Overall Survival (OS) (up to 6 years)
- • Progression Free Survival (PFS) (up to 6 years)
Sponsor
NovoCure GmbH · industry
All locations (98)
Central Alabama ResearchRecruiting
Birmingham, Alabama, United States
Western Regional Medical Center, LLCRecruiting
Goodyear, Arizona, United States
St. Jude Herritage Medical GroupRecruiting
Fullerton, California, United States
Hoag Family Cancer Institute - Hoag Memorial HospitalRecruiting
Newport Beach, California, United States
Sutter Institute for Medical ResearchRecruiting
Sacramento, California, United States
Florida Cancer Affiliates - Ocala OncologyRecruiting
Ocala, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Northwest Oncology & HematologyRecruiting
Barrington, Illinois, United States
Elmhurst Hospital Nancy Knowles Cancer CenterRecruiting
Elmhurst, Illinois, United States
Edward Cancer CenterRecruiting
Naperville, Illinois, United States
Cancer Treatment Centers of America (CTCA)Recruiting
Zion, Illinois, United States
Parkview Packnett Family Cancer InstituteRecruiting
Fort Wayne, Indiana, United States
Franciscan Health IndianapolisRecruiting
Indianapolis, Indiana, United States
University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
Luminis Health Radiation Oncology - Anne Arundel Health SystemRecruiting
Annapolis, Missouri, United States
University of Kansas Cancer Center - NorthRecruiting
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's SummitRecruiting
Lee's Summit, Missouri, United States
University of Kansas Cancer Center - Overland ParkRecruiting
Overland, Missouri, United States
New York Cancer & Blood Specialists (NYCBS)Recruiting
New Hyde Park, New York, United States
New York Cancer & Blood Specialists (NYCBS)Recruiting
New York, New York, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
New York Cancer & Blood Specialists (NYCBS)Recruiting
Shirley, New York, United States
New York Cancer & Blood Specialists (NYCBS)Recruiting
The Bronx, New York, United States
WakeMed Health & HospitalsRecruiting
Cary, North Carolina, United States
Abramson Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
AHN Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Old Parkland Hospital Hematology Oncology ClinicRecruiting
Dallas, Texas, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
DHR Health Oncology InstituteRecruiting
Edinburg, Texas, United States
Houston Methodist Cancer CenterRecruiting
Houston, Texas, United States
Methodist Richardson Cancer CenterRecruiting
Richardson, Texas, United States
Jason Bates at University of Texas Health Science CenterRecruiting
San Antonio, Texas, United States
MultiCare Regional Cancer CenterRecruiting
Auburn, Washington, United States
MultiCare Regional Cancer CenterRecruiting
Gig Harbor, Washington, United States
MultiCare Regional Cancer CenterRecruiting
Puyallup, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - DowntownRecruiting
Spokane, Washington, United States
MultiCare Institute for Research & InnovationRecruiting
Tacoma, Washington, United States
Universitaetsklinik fuer Innere Medizin V InnsbruckRecruiting
Innsbruck, Austria
University Hospital SalzburgRecruiting
Salzburg, Austria
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik FloridsdorfRecruiting
Vienna, Austria
Cliniques universitaires Saint-LucRecruiting
Brussels, Belgium
AZ Maria Middelares - Campus Maria MiddelaresRecruiting
Ghent, Belgium
Fakultni nemocnice Olomouc FNOLRecruiting
Olomouc, Czechia
Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice HospitalRecruiting
Ostrava, Czechia
General University Hospital in PragueRecruiting
Prague, Czechia
Centre Hospitalier Intercommunal de CreteilRecruiting
Créteil, France
CHU LimogesRecruiting
Limoges, France
Hopital EuropeenRecruiting
Marseille, France
Hopital Prive du ConfluentRecruiting
Nantes, France
Institut CurieRecruiting
Paris, France
CHU de BordeauxRecruiting
Pessac, France
Centre Hospitalier Lyon SudRecruiting
Pierre-Bénite, France
Nouvel Hopital Civil (NHC)Recruiting
Strasbourg, France
Evangelische Lungenklinik BerlinRecruiting
Berlin, Germany
University Hospital Giessen, ZIM IVRecruiting
Giessen, Germany
Krankenhaus Martha-Maria Halle-DolauRecruiting
Halle, Germany
Thoraxklinik HeidelbergRecruiting
Heidelberg, Germany
Klinik Loewenstein gGmbHRecruiting
Löwenstein, Germany
Pius-Hospital OldenburgRecruiting
Oldenburg, Germany
Farkasgyepui TudogyogyintezetRecruiting
Farkasgyepű, Hungary
Bacs-Kiskun Varmegyei OktatokorhazRecruiting
Kecskemét, Hungary
Tolna Varmegyei Balassa Janos KorhazRecruiting
Szekszárd, Hungary
Emek Medical CenterRecruiting
Afula, Israel
Bnai zion MCRecruiting
Haifa, Israel
A.O. SS. Antonio e Biagio e Cesare Arrigo di AlessandriaRecruiting
Alessandria, Italy
Humanitas GavazzeniRecruiting
Bergamo, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'AnnaRecruiting
Ferrara, Italy
IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino AmadoriRecruiting
Meldola, Italy
Azienda Sanitaria Territoriale Pesaro UrbinoRecruiting
Pesaro, Italy
Universita Campus Bio-Medico di Roma (UCBM) - Policlinico UniversitarioRecruiting
Roma, Italy
Ospedale Isola Tiberina GemelliRecruiting
Rome, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le ScotteRecruiting
Siena, Italy
Saitama Medical University International Medical CenterRecruiting
Hidaka, Saitama, Japan
Rijnstate ZiekenhuisRecruiting
Arnhem, Netherlands
Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)Recruiting
Friesland, Netherlands
St. Jansdal ziekenhuisRecruiting
Harderwijk, Netherlands
St Antonius ZiekenhuisRecruiting
Utrecht, Netherlands
Uniwersytecki Szpital KlinicznyRecruiting
Poznan, Poland
NCCS SingaporeRecruiting
Singapore, Singapore
Curie OncologyRecruiting
Singapore, Singapore
Icon Cancer Centre Singapore (Singapore Oncology Consultants)Recruiting
Singapore, Singapore
Hospital Universitario del VinalopoRecruiting
Elche, Alicante, Spain
Hospital Universitario Virgen del RocioRecruiting
Seville, Andalusia, Spain
Clinica Mi Tres Torres Barcelona - Giromed InstituteRecruiting
Barcelona, Catalonia, Spain
Hospital Universitario de TorrejonRecruiting
Torrejón de Ardoz, Madrid, Spain
Institut Catala d'OncologiaRecruiting
Barcelona, Spain
Hospital Universitario Arnau de VilanovaRecruiting
Lleida, Spain
Clinica Universidad de Navarra (Madrid)Recruiting
Madrid, Spain
Hospital Ruber InternacionalRecruiting
Madrid, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Clinica Universidad de NavarraRecruiting
Pamplona, Spain
Cantonal Hospital BadenRecruiting
Baden, Switzerland
HFR Freiburg-KantonsspitalRecruiting
Fribourg, Switzerland
Charing Cross HospitalRecruiting
London, Greater London, United Kingdom
University Hospitals of Leicester NHS TrustRecruiting
Leicester, Leicestershire, United Kingdom
The Royal Marsden NHS Foundation TrustRecruiting
London, London, United Kingdom
Clatterbridge Cancer Centre - LiverpoolRecruiting
Liverpool, Merseyside, United Kingdom
The Royal Marsden NHS Foundation Trust - SuttonRecruiting
Sutton, Sutton, United Kingdom