Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06216301

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

Led by NovoCure GmbH · Updated on 2025-12-17

734

Participants Needed

90

Research Sites

217 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer.

CONDITIONS

Official Title

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 22 years or older in the USA, 18 years or older outside the USA
  • Confirmed stage 4 non-squamous or squamous NSCLC diagnosis
  • Measurable or non-measurable disease in the chest area
  • No prior systemic treatment for metastatic NSCLC
  • ECOG performance status of 0 or 1
  • Adequate blood and organ function
  • For females, not pregnant or breastfeeding
  • Males with female partners of childbearing potential agree to use effective contraception
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Mixed small cell and NSCLC histology
  • Presence of certain gene mutations or rearrangements requiring targeted therapy
  • 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 without recovery
  • Need for other antineoplastic therapy during the study
  • Active progressing second cancer requiring treatment within 3 years (some skin or in situ cancers excluded)
  • Symptomatic CNS metastases or carcinomatous meningitis
  • Active autoimmune disease needing systemic treatment in past 2 years
  • Immunodeficiency or recent use of high-dose steroids or immunosuppressants
  • Prior treatment with anti-PD-1/PD-L1 agents within 12 months
  • Participation in other investigational studies within 4 weeks
  • Concurrent experimental NSCLC treatments
  • Known sensitivity to study drugs
  • Pregnant or breastfeeding
  • Institutionalized by administrative or court order

AI-Screening

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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

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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