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RecruitingInterventionalPhase 3

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

NCT ID: NCT06216301Sponsor: NovoCure GmbHLast updated: 2025-12-17

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.

Detailed description

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.

Arms & interventions

  • DeviceNovoTTF-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.

  • DrugPembrolizumab

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

  • DrugPlatinum based chemotherapy

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

Outcome measures

Primary

  • 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).

    Time frame: 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)

    Time frame: up to 6 years

Secondary

  • Progression Free Survival (PFS)

    Time frame: up to 6 years

  • Overall Survival (OS)

    Time frame: up to 6 years

  • Progression Free Survival (PFS)

    Time frame: up to 6 years

  • Overall Survival (OS)

    Time frame: up to 6 years

  • Progression Free Survival (PFS)

    Time frame: up to 6 years

  • 1, 2, and 3-year Survival Rate

    Time frame: up to 6 years

  • Objective Response Rate (ORR)

    Time frame: up to 6 years

  • Duration of Response (DoR)

    Time frame: up to 6 years

  • Disease Control Rate (DCR)

    Time frame: up to 6 years

  • Progression Free Survival (PFS)

    Time frame: up to 6 years

  • Objective Response Rate (ORR)

    Time frame: up to 6 years

  • Duration of Response (DoR)

    Time frame: up to 6 years

  • Disease Control Rate (DCR)

    Time frame: up to 6 years

  • Adverse Events

    Time frame: up to 6 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (35)

Central Alabama Research

Birmingham, Alabama, 35209

Recruiting

Western Regional Medical Center, LLC

Goodyear, Arizona, 85338

Recruiting

St. Jude Herritage Medical Group

Fullerton, California, 92835

Recruiting

Hoag Family Cancer Institute - Hoag Memorial Hospital

Newport Beach, California, 92663

Recruiting
Patrice Jones · Contact

Sutter Institute for Medical Research

Sacramento, California, 95816

Recruiting

Florida Cancer Affiliates - Ocala Oncology

Ocala, Florida, 34474

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Northwest Oncology & Hematology

Barrington, Illinois, 60010

Recruiting

Elmhurst Hospital Nancy Knowles Cancer Center

Elmhurst, Illinois, 60126

Recruiting

Edward Cancer Center

Naperville, Illinois, 60540-6766

Recruiting

Cancer Treatment Centers of America (CTCA)

Zion, Illinois, 60099

Recruiting
Sylvia Schneiderman · Contact

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237

Recruiting

University of Kansas Cancer Center

Westwood, Kansas, 66205

Recruiting
KUCC Navigation · Contact

Luminis Health Radiation Oncology - Anne Arundel Health System

Annapolis, Missouri, 21401

Recruiting

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154

Recruiting
KUCC Navigation · Contact

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064

Recruiting
KUCC Navigation · Contact

University of Kansas Cancer Center - Overland Park

Overland, Missouri, 66210

Recruiting
KUCC Navigation · Contact

New York Cancer & Blood Specialists (NYCBS)

New Hyde Park, New York, 11042

Recruiting
Laura Parisi · Contact

New York Cancer & Blood Specialists (NYCBS)

New York, New York, 10028

Recruiting
Laura Parisi · Contact

University of Rochester Medical Center

Rochester, New York, 14642

Recruiting

New York Cancer & Blood Specialists (NYCBS)

Shirley, New York, 19967

Recruiting
Laura Parisi · Contact

New York Cancer & Blood Specialists (NYCBS)

The Bronx, New York, 10469

Recruiting
Laura Parisi · Contact

WakeMed Health & Hospitals

Cary, North Carolina, 27518

Recruiting
Taylor Childress · Contact

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Recruiting

AHN Cancer Center

Pittsburgh, Pennsylvania, 15212

Recruiting
Ariel Lopez-Chavez · Contact

Old Parkland Hospital Hematology Oncology Clinic

Dallas, Texas, 75235

Recruiting

UT Southwestern Medical Center

Dallas, Texas, 75235

Recruiting

DHR Health Oncology Institute

Edinburg, Texas, 78539

Recruiting
Edgar Lopez · Contact

Methodist Richardson Cancer Center

Richardson, Texas, 75082

Recruiting
Crystee Cooper · Contact

Jason Bates at University of Texas Health Science Center

San Antonio, Texas, 78229

Recruiting
Epp Goodwin · Contact

MultiCare Regional Cancer Center

Auburn, Washington, 98001

Recruiting

MultiCare Regional Cancer Center

Gig Harbor, Washington, 98335

Recruiting

MultiCare Regional Cancer Center

Puyallup, Washington, 98372

Recruiting

MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

Spokane, Washington, 99218

Recruiting

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405

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