Recruiting
Phase 3

TTFields & Pembrolizumab

Sponsor:

NovoCure GmbH

Code:

NCT06216301

Conditions

Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NovoTTF-200T

Pembrolizumab

Platinum based chemotherapy

Study Details

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

Study ID

NCT06216301

Start date

Jul 31, 2024

Status verified date

Dec, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

734 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

active comparator: Arm 2: Pembrolizumab and Platinum-based Chemotherapy

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

Interventions

NovoTTF-200T

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.

Pembrolizumab

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

Platinum based chemotherapy

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

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: up to 6 years ]
  • Progression Free Survival (PFS) [ Time Frame: up to 6 years ]

Central Contacts and Locations

Locations

Central Alabama Research

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Lorie Szymela

205-949-1907lszymela@centralalabamaresearch.com

Western Regional Medical Center, LLC

Recruiting

Goodyear, Arizona, United States, 85338

Contacts

Janiece Denaro

1- 623-207-3196Janiece.Denaro@ctca-hope.com

St. Jude Herritage Medical Group

Recruiting

Fullerton, California, United States, 92835

Contacts

Larissa Ulloa

800-627-8106larissa.lacson@providence.org

Hoag Family Cancer Institute - Hoag Memorial Hospital

Recruiting

Newport Beach, California, United States, 92663

Contacts

Patrice Jones

949-764-5501Patrice.Jones@hoag.org

Sutter Institute for Medical Research

Recruiting

Sacramento, California, United States, 95816

Contacts

Clara Dunn

1-916-454-6931Clara.Dunn@sutterhealth.org

Baptist MD Anderson Cancer Center, Baptist Health

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Vanessa Tolsa

305-915-6496vanessa.tolsa@bmcjax.com

Principal Investigator:

John Vu

Florida Cancer Affiliates - Ocala Oncology

Recruiting

Ocala, Florida, United States, 34474

Contacts

Megan Cerrato

352-547-1943Megan.Cerrato@usoncology.com

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Maya Douglas

813-745-0969maya.douglas@moffitt.org

Northwest Oncology & Hematology

Recruiting

Barrington, Illinois, United States, 60010

Contacts

Khalada Admad

224-273-8971khalada.ahmad@ascension.org

Elmhurst Hospital Nancy Knowles Cancer Center

Recruiting

Elmhurst, Illinois, United States, 60126

Contacts

Jessica Schnase

630-646-6029Jessica.Schnase@EEHealth.org

Edward Cancer Center

Recruiting

Naperville, Illinois, United States, 60540-6766

Contacts

Jessica Schnase

630-646-6029Jessica.Schnase@EEHealth.org

Cancer Treatment Centers of America (CTCA)

Recruiting

Zion, Illinois, United States, 60099

Contacts

Sylvia Schneiderman

1-847-746-6983sylvia.schneiderman@coh.org

Parkview Packnett Family Cancer Institute

Recruiting

Fort Wayne, Indiana, United States, 46845

Contacts

Brian Chang, Dr.

1-833-724-8326brian2.chang@parkview.com

Principal Investigator:

Brian Chang

Franciscan Health Indianapolis

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Olivia Martin

317-528-7822Olivia.martin@franciscanalliance.org

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

Luminis Health Radiation Oncology - Anne Arundel Health System

Recruiting

Annapolis, Missouri, United States, 21401

Contacts

Rachael Niedelman

443 659 8685rniedelman@velocityclinical.com

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

University of Kansas Cancer Center - Overland Park

Recruiting

Overland, Missouri, United States, 66210

Contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

New York Cancer & Blood Specialists (NYCBS)

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

Laura Parisi

631-675-5146lparisi@nycancer.com

New York Cancer & Blood Specialists (NYCBS)

Recruiting

New York, New York, United States, 10028

Contacts

Laura Parisi

631-675-5146lparisi@nycancer.com

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Sierra Napoli

585-276-0648Sierra_Napoli@URMC.Rochester.edu

New York Cancer & Blood Specialists (NYCBS)

Recruiting

Shirley, New York, United States, 19967

Contacts

Laura Parisi

631-675-5146lparisi@nycancer.com

New York Cancer & Blood Specialists (NYCBS)

Recruiting

The Bronx, New York, United States, 10469

Contacts

Laura Parisi

631-675-5146lparisi@nycancer.com

WakeMed Health & Hospitals

Recruiting

Cary, North Carolina, United States, 27518

Contacts

Taylor Childress

919-350-1700tchildress@wakemed.org

Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Ryan Roddy

267-408-3199ryan.roddy@pennmedicine.upenn.edu

AHN Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Ariel Lopez-Chavez

412-518-5025clinicaltrials@ahn.org

Old Parkland Hospital Hematology Oncology Clinic

Recruiting

Dallas, Texas, United States, 75235

Contacts

Ebele Mbanugo

214-645-0326ebele.mbanugo@utsouthwestern.edu

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Ebele Mbanugo

214-645-0326ebele.mbanugo@utsouthwestern.edu

DHR Health Oncology Institute

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Edgar Lopez

956-362-2394ed.lopez@dhr-rgv.com

Houston Methodist Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Nicole Barrios

713-441-5607nkbarrios@houstonmethodist.org

Principal Investigator:

Jun Zhang

Methodist Richardson Cancer Center

Recruiting

Richardson, Texas, United States, 75082

Contacts

Crystee Cooper

214-947-1280ClinicalResearch@mhd.com

Jason Bates at University of Texas Health Science Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Epp Goodwin

210-450-5798goodwine@uthscsa.edu

MultiCare Regional Cancer Center

Recruiting

Auburn, Washington, United States, 98001

Contacts

Stacey Macon

1-253-403-0791Stacey.macon@multicare.org

MultiCare Regional Cancer Center

Recruiting

Gig Harbor, Washington, United States, 98335

Contacts

Stacey Macon

1-253-403-0791Stacey.macon@multicare.org

MultiCare Regional Cancer Center

Recruiting

Puyallup, Washington, United States, 98372

Contacts

Stacey Macon

1-253-403-0791Stacey.macon@multicare.org

MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

Recruiting

Spokane, Washington, United States, 99218

Contacts

Rachel Smith

1-509-838-2531rachel.smith@multicare.org

MultiCare Institute for Research & Innovation

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Stacey Macon

1-253-403-0791Stacey.macon@multicare.org

The Ottawa Hospital Cancer Centre General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Garth Nicholas

613-737-7700gnicholas@toh.ca

Principal Investigator:

Garth Nicholas

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Vaishali Krishnanandan

416-480-5000vaishali.krishnanandan@sunnybrook.ca

Principal Investigator:

Susanna Cheng

More Information

Sponsor

NovoCure GmbH

Last update posted

Oct 6, 2026

Last verified

Dec, 2025

Keywords

  • NSCLC
  • Metastatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by NovoCure GmbH on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.