Actively Recruiting
LUNAR-2: Randomized Study of Tumor Treating Fields (TTFields) with Pembrolizumab and Platinum-based Chemotherapy for Metastatic Non-Small Cell Lung Cancer
Led by NovoCure GmbH · Updated on 2025-12-17
734
Participants Needed
90
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Tumor Treating Fields (TTFields) delivered by the NovoTTF-200T device together with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body. This pivotal, randomized, open-label study aims to assess overall survival and progression-free survival, with additional analysis based on lung cancer subtype and PD-L1 expression. Participants have an ECOG performance status of 0-1 and are stratified by histology, PD-L1 levels, and prior immunotherapy treatment. The study has two groups: one receives TTFields using the portable NovoTTF-200T device along with pembrolizumab and platinum-based chemotherapy, while the other group receives pembrolizumab and platinum-based chemotherapy alone. TTFields are delivered continuously at a frequency of 150kHz through insulated transducer arrays intended to disrupt cancer cell division. Treatments are administered according to the study protocol, and participants are followed to compare outcomes between these approaches. During the study, participants undergo regular assessments including measurements of disease progression by RECIST v1.1 criteria and evaluations of survival over up to six years. Researchers monitor adverse events and response rates while gathering data on disease control and duration of response. The study collects detailed information on safety and effectiveness to better understand these treatments for metastatic NSCLC over the long term.
CONDITIONS
Brief Title
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 22 years of age or older in the USA; 18 years or older outside the USA
- Diagnosis of stage 4 non-squamous or squamous non-small cell lung cancer confirmed by tissue examination
- Measurable or non-measurable disease in the chest area per RECIST v1.1 criteria
- No prior systemic treatment for metastatic NSCLC; previous curative chemotherapy completed at least 12 months before metastatic disease
- ECOG performance status of 0 or 1
- Adequate blood and organ function
- For those not on blood thinners, specific blood clotting test results within normal limits
- Female participants must not be pregnant or breastfeeding
- Male participants with female partners of childbearing potential must use effective contraception
- Signed written informed consent
You will not qualify if you...
- Mixed small cell and non-small cell lung cancer histology
- Presence of certain genetic mutations requiring targeted therapy (EGFR, ALK, ROS1, RET, METex14, NTRK1/2, BRAF V600)
- Prior systemic therapy for metastatic disease
- Major surgery within 3 weeks before randomization
- Lung radiation over 30 Gy within 6 months before randomization
- Radiation therapy within 2 weeks before randomization unless recovered and stable
- Need for other anti-cancer therapies during the study
- Another progressing cancer requiring treatment within last 3 years (except certain skin or in situ cancers)
- Symptomatic brain metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Active autoimmune disease needing systemic treatment in past 2 years
- Immunodeficiency or recent high-dose steroid or immunosuppressive treatment
- Prior anti-PD-1, PD-L1, PD-L2, or related immunotherapy within 12 months
- Participation in other investigational studies within 4 weeks
- Concurrent experimental treatments for NSCLC
- Known allergy to study drugs (pembrolizumab, cisplatin/carboplatin, pemetrexed/paclitaxel/nab-paclitaxel)
- Pregnancy or breastfeeding
- Institutionalization by administrative or court order
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants begin baseline assessments and preparation prior to starting treatment.
1 baseline visit
Duration - Up to 6 years or until disease progression or discontinuation
Participants receive active treatment with pembrolizumab and platinum-based chemotherapy, with some also receiving Tumor Treating Fields using the NovoTTF-200T device.
Regular visits for treatment administration and monitoring
Duration - Up to 6 years
Participants are monitored for overall survival, progression free survival, adverse events, and disease response after treatment ends.
Periodic visits for up to 6 years
Trial Site Locations
Total: 90 locations
1
Central Alabama Research
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Western Regional Medical Center, LLC
Goodyear, Arizona, United States, 85338
Actively Recruiting
3
St. Jude Herritage Medical Group
Fullerton, California, United States, 92835
Actively Recruiting
4
Hoag Family Cancer Institute - Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
5
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
Actively Recruiting
6
Florida Cancer Affiliates - Ocala Oncology
Ocala, Florida, United States, 34474
Actively Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
8
Northwest Oncology & Hematology
Barrington, Illinois, United States, 60010
Actively Recruiting
9
Elmhurst Hospital Nancy Knowles Cancer Center
Elmhurst, Illinois, United States, 60126
Actively Recruiting
10
Edward Cancer Center
Naperville, Illinois, United States, 60540-6766
Actively Recruiting
11
Cancer Treatment Centers of America (CTCA)
Zion, Illinois, United States, 60099
Actively Recruiting
12
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
Actively Recruiting
13
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
14
Luminis Health Radiation Oncology - Anne Arundel Health System
Annapolis, Missouri, United States, 21401
Actively Recruiting
15
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
16
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
17
University of Kansas Cancer Center - Overland Park
Overland, Missouri, United States, 66210
Actively Recruiting
18
New York Cancer & Blood Specialists (NYCBS)
New Hyde Park, New York, United States, 11042
Actively Recruiting
19
New York Cancer & Blood Specialists (NYCBS)
New York, New York, United States, 10028
Actively Recruiting
20
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
21
New York Cancer & Blood Specialists (NYCBS)
Shirley, New York, United States, 19967
Actively Recruiting
22
New York Cancer & Blood Specialists (NYCBS)
The Bronx, New York, United States, 10469
Actively Recruiting
23
WakeMed Health & Hospitals
Cary, North Carolina, United States, 27518
Actively Recruiting
24
Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
AHN Cancer Center
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
26
Old Parkland Hospital Hematology Oncology Clinic
Dallas, Texas, United States, 75235
Actively Recruiting
27
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
28
DHR Health Oncology Institute
Edinburg, Texas, United States, 78539
Actively Recruiting
29
Methodist Richardson Cancer Center
Richardson, Texas, United States, 75082
Actively Recruiting
30
Jason Bates at University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Actively Recruiting
31
MultiCare Regional Cancer Center
Auburn, Washington, United States, 98001
Actively Recruiting
32
MultiCare Regional Cancer Center
Gig Harbor, Washington, United States, 98335
Actively Recruiting
33
MultiCare Regional Cancer Center
Puyallup, Washington, United States, 98372
Actively Recruiting
34
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, United States, 99218
Actively Recruiting
35
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States, 98405
Actively Recruiting
36
Universitaetsklinik fuer Innere Medizin V Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
37
University Hospital Salzburg
Salzburg, Austria, 5020
Actively Recruiting
38
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Vienna, Austria, 1210
Actively Recruiting
39
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
40
AZ Maria Middelares - Campus Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
41
Fakultni nemocnice Olomouc FNOL
Olomouc, Czechia, 779 00
Actively Recruiting
42
Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital
Ostrava, Czechia, 70300
Actively Recruiting
43
General University Hospital in Prague
Prague, Czechia, 12808
Actively Recruiting
44
Centre Hospitalier Intercommunal de Creteil
Créteil, France, 94010
Actively Recruiting
45
CHU Limoges
Limoges, France, 87000
Actively Recruiting
46
Hopital Europeen
Marseille, France, 13003
Actively Recruiting
47
Hopital Prive du Confluent
Nantes, France, 44277
Actively Recruiting
48
Institut Curie
Paris, France, 75005
Actively Recruiting
49
CHU de Bordeaux
Pessac, France, 33604
Actively Recruiting
50
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
51
Nouvel Hopital Civil (NHC)
Strasbourg, France, 67091
Actively Recruiting
52
Evangelische Lungenklinik Berlin
Berlin, Germany, 13125
Actively Recruiting
53
University Hospital Giessen, ZIM IV
Giessen, Germany, 35392
Actively Recruiting
54
Krankenhaus Martha-Maria Halle-Dolau
Halle, Germany, 06120
Actively Recruiting
55
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
Actively Recruiting
56
Klinik Loewenstein gGmbH
Löwenstein, Germany, 74245
Actively Recruiting
57
Pius-Hospital Oldenburg
Oldenburg, Germany, 26121
Actively Recruiting
58
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Hungary, 8582
Actively Recruiting
59
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, Hungary, 6000
Actively Recruiting
60
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, Hungary, 7100
Actively Recruiting
61
Emek Medical Center
Afula, Israel, 1834111
Actively Recruiting
62
Bnai zion MC
Haifa, Israel, 34561
Actively Recruiting
63
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, Italy, 15121
Actively Recruiting
64
Humanitas Gavazzeni
Bergamo, Italy, 24125
Actively Recruiting
65
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara, Italy, 44124
Actively Recruiting
66
IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori
Meldola, Italy, 47014
Actively Recruiting
67
Azienda Sanitaria Territoriale Pesaro Urbino
Pesaro, Italy, 61122
Actively Recruiting
68
Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario
Roma, Italy, 00128
Actively Recruiting
69
Ospedale Isola Tiberina Gemelli
Rome, Italy, 00186
Actively Recruiting
70
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, Italy, 53100
Actively Recruiting
71
Rijnstate Ziekenhuis
Arnhem, Netherlands, 6815AD
Actively Recruiting
72
Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)
Friesland, Netherlands, 8934 AD
Actively Recruiting
73
St. Jansdal ziekenhuis
Harderwijk, Netherlands, 3844 DG
Actively Recruiting
74
St Antonius Ziekenhuis
Utrecht, Netherlands, 3543 AZ
Actively Recruiting
75
Uniwersytecki Szpital Kliniczny
Poznan, Poland, 60-693
Actively Recruiting
76
NCCS Singapore
Singapore, Singapore, 168583
Actively Recruiting
77
Curie Oncology
Singapore, Singapore, 329563
Actively Recruiting
78
Icon Cancer Centre Singapore (Singapore Oncology Consultants)
Singapore, Singapore, 574623
Actively Recruiting
79
Hospital Universitario del Vinalopo
Elche, Alicante, Spain, 3293
Actively Recruiting
80
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain, 41013
Actively Recruiting
81
Clinica Mi Tres Torres Barcelona - Giromed Institute
Barcelona, Catalonia, Spain, 8017
Actively Recruiting
82
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, Spain, 28850
Actively Recruiting
83
Institut Catala d'Oncologia
Barcelona, Spain, 8916
Actively Recruiting
84
Hospital Universitario Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
85
Clinica Universidad de Navarra (Madrid)
Madrid, Spain, 28027
Actively Recruiting
86
Hospital Ruber Internacional
Madrid, Spain, 28034
Actively Recruiting
87
Hospital Regional Universitario de Malaga
Málaga, Spain, 29010
Actively Recruiting
88
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
89
Cantonal Hospital Baden
Baden, Switzerland, 5404
Actively Recruiting
90
HFR Freiburg-Kantonsspital
Fribourg, Switzerland, 1752
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here