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

NCT06216301 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: EF-44
• Study Type: interventional
• Target: 734
• Locations: 14 countries
• Sites: 90

Brief Summary

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

Metastatic Non-small Cell Lung Cancer

Keywords

NSCLC; Metastatic

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  To compare OS in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to OS of those treated with pembrolizumab and platinum-based chemotherapy alone (superiority analysis).

  up to 6 years

• Progression Free Survival (PFS)

  To compare PFS per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to PFS of those treated with pembrolizumab and platinum-based chemotherapy alone (superiority analysis)

  up to 6 years

Secondary Outcomes (14)

• Progression Free Survival (PFS)

  up to 6 years

• Overall Survival (OS)

  up to 6 years

• Progression Free Survival (PFS)

  up to 6 years

• Overall Survival (OS)

  up to 6 years

• Progression Free Survival (PFS)

  up to 6 years

Study Arms (2)

Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy

EXPERIMENTAL

Subjects in this arm receive three treatments - TTFields using the NovoTTF-200T device, pembrolizumab, and platinum-based chemotherapy.

Device: NovoTTF-200T; Drug: Pembrolizumab; Drug: Platinum based chemotherapy

Arm 2: Pembrolizumab and Platinum-based Chemotherapy

ACTIVE COMPARATOR

Subjects in this arm receive two treatments - pembrolizumab and platinum-based chemotherapy.

Drug: Pembrolizumab; Drug: Platinum based chemotherapy

Interventions

NovoTTF-200T DEVICE

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 physically disrupt the rapid cell division exhibited by cancer cells. The physical disruption induced by TTFields can lead to to downstream immunogenic cell death.

Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy

Pembrolizumab DRUG

Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.

Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy; Arm 2: Pembrolizumab and Platinum-based Chemotherapy

Platinum based chemotherapy DRUG

Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer

Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy; Arm 2: Pembrolizumab and Platinum-based Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovoCure GmbH: lead

Study Sites (90)

Central Alabama Research

Birmingham, Alabama, 35209, United States

RECRUITING

Western Regional Medical Center, LLC

Goodyear, Arizona, 85338, United States

RECRUITING

St. Jude Herritage Medical Group

Fullerton, California, 92835, United States

RECRUITING

Hoag Family Cancer Institute - Hoag Memorial Hospital

Newport Beach, California, 92663, United States

RECRUITING

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

RECRUITING

Florida Cancer Affiliates - Ocala Oncology

Ocala, Florida, 34474, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Northwest Oncology & Hematology

Barrington, Illinois, 60010, United States

RECRUITING

Elmhurst Hospital Nancy Knowles Cancer Center

Elmhurst, Illinois, 60126, United States

RECRUITING

Edward Cancer Center

Naperville, Illinois, 60540-6766, United States

RECRUITING

Cancer Treatment Centers of America (CTCA)

Zion, Illinois, 60099, United States

RECRUITING

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

RECRUITING

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Luminis Health Radiation Oncology - Anne Arundel Health System

Annapolis, Missouri, 21401, United States

RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

University of Kansas Cancer Center - Overland Park

Overland, Missouri, 66210, United States

RECRUITING

New York Cancer & Blood Specialists (NYCBS)

New Hyde Park, New York, 11042, United States

RECRUITING

New York Cancer & Blood Specialists (NYCBS)

New York, New York, 10028, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

New York Cancer & Blood Specialists (NYCBS)

Shirley, New York, 19967, United States

RECRUITING

New York Cancer & Blood Specialists (NYCBS)

The Bronx, New York, 10469, United States

RECRUITING

WakeMed Health & Hospitals

Cary, North Carolina, 27518, United States

RECRUITING

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

AHN Cancer Center

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Old Parkland Hospital Hematology Oncology Clinic

Dallas, Texas, 75235, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

DHR Health Oncology Institute

Edinburg, Texas, 78539, United States

RECRUITING

Methodist Richardson Cancer Center

Richardson, Texas, 75082, United States

RECRUITING

Jason Bates at University of Texas Health Science Center

San Antonio, Texas, 78229, United States

RECRUITING

MultiCare Regional Cancer Center

Auburn, Washington, 98001, United States

RECRUITING

MultiCare Regional Cancer Center

Gig Harbor, Washington, 98335, United States

RECRUITING

MultiCare Regional Cancer Center

Puyallup, Washington, 98372, United States

RECRUITING

MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

Spokane, Washington, 99218, United States

RECRUITING

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

RECRUITING

Universitaetsklinik fuer Innere Medizin V Innsbruck

Innsbruck, 6020, Austria

RECRUITING

University Hospital Salzburg

Salzburg, 5020, Austria

RECRUITING

Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf

Vienna, 1210, Austria

RECRUITING

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

AZ Maria Middelares - Campus Maria Middelares

Ghent, 9000, Belgium

RECRUITING

Fakultni nemocnice Olomouc FNOL

Olomouc, 779 00, Czechia

RECRUITING

Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital

Ostrava, 70300, Czechia

RECRUITING

General University Hospital in Prague

Prague, 12808, Czechia

RECRUITING

Centre Hospitalier Intercommunal de Creteil

Créteil, 94010, France

RECRUITING

CHU Limoges

Limoges, 87000, France

RECRUITING

Hopital Europeen

Marseille, 13003, France

RECRUITING

Hopital Prive du Confluent

Nantes, 44277, France

RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

CHU de Bordeaux

Pessac, 33604, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

Nouvel Hopital Civil (NHC)

Strasbourg, 67091, France

RECRUITING

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

RECRUITING

University Hospital Giessen, ZIM IV

Giessen, 35392, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Dolau

Halle, 06120, Germany

RECRUITING

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

RECRUITING

Klinik Loewenstein gGmbH

Löwenstein, 74245, Germany

RECRUITING

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

RECRUITING

Farkasgyepui Tudogyogyintezet

Farkasgyepű, 8582, Hungary

RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz

Kecskemét, 6000, Hungary

RECRUITING

Tolna Varmegyei Balassa Janos Korhaz

Szekszárd, 7100, Hungary

RECRUITING

Emek Medical Center

Afula, 1834111, Israel

RECRUITING

Bnai zion MC

Haifa, 34561, Israel

RECRUITING

A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Alessandria, 15121, Italy

RECRUITING

Humanitas Gavazzeni

Bergamo, 24125, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

Ferrara, 44124, Italy

RECRUITING

IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori

Meldola, 47014, Italy

RECRUITING

Azienda Sanitaria Territoriale Pesaro Urbino

Pesaro, 61122, Italy

RECRUITING

Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario

Roma, 00128, Italy

RECRUITING

Ospedale Isola Tiberina Gemelli

Rome, 00186, Italy

RECRUITING

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

Siena, 53100, Italy

RECRUITING

Rijnstate Ziekenhuis

Arnhem, 6815AD, Netherlands

RECRUITING

Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)

Friesland, 8934 AD, Netherlands

RECRUITING

St. Jansdal ziekenhuis

Harderwijk, 3844 DG, Netherlands

RECRUITING

St Antonius Ziekenhuis

Utrecht, 3543 AZ, Netherlands

RECRUITING

Uniwersytecki Szpital Kliniczny

Poznan, 60-693, Poland

RECRUITING

NCCS Singapore

Singapore, 168583, Singapore

RECRUITING

Curie Oncology

Singapore, 329563, Singapore

RECRUITING

Icon Cancer Centre Singapore (Singapore Oncology Consultants)

Singapore, 574623, Singapore

RECRUITING

Hospital Universitario del Vinalopo

Elche, Alicante, 3293, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

RECRUITING

Clinica Mi Tres Torres Barcelona - Giromed Institute

Barcelona, Catalonia, 8017, Spain

RECRUITING

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, 28850, Spain

RECRUITING

Institut Catala d'Oncologia

Barcelona, 8916, Spain

RECRUITING

Hospital Universitario Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Clinica Universidad de Navarra (Madrid)

Madrid, 28027, Spain

RECRUITING

Hospital Ruber Internacional

Madrid, 28034, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

Cantonal Hospital Baden

Baden, 5404, Switzerland

RECRUITING

HFR Freiburg-Kantonsspital

Fribourg, 1752, Switzerland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

pembrolizumab; Platinum Compounds

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 22, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); AU (3); US (35); DE (6); SG (3); IL (2); NL (4); ES (10); CH (2); BE (2); IT (8); HU (3); PL (1); FR (8)