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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy 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.
Primary outcome measure(s)
Overall Survival (OS) — up to 6 years 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).
Progression Free Survival (PFS) — up to 6 years 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)
Trial sites (98)
Facility
City
Region
Status
Central Alabama Research
Birmingham
Alabama
Recruiting
Western Regional Medical Center, LLC
Goodyear
Arizona
Recruiting
St. Jude Herritage Medical Group
Fullerton
California
Recruiting
Hoag Family Cancer Institute - Hoag Memorial Hospital
Newport Beach
California
Recruiting
Sutter Institute for Medical Research
Sacramento
California
Recruiting
Florida Cancer Affiliates - Ocala Oncology
Ocala
Florida
Recruiting
Moffitt Cancer Center
Tampa
Florida
Recruiting
Northwest Oncology & Hematology
Barrington
Illinois
Recruiting
Elmhurst Hospital Nancy Knowles Cancer Center
Elmhurst
Illinois
Recruiting
Edward Cancer Center
Naperville
Illinois
Recruiting
Cancer Treatment Centers of America (CTCA)
Zion
Illinois
Recruiting
Parkview Packnett Family Cancer Institute
Fort Wayne
Indiana
Recruiting
Franciscan Health Indianapolis
Indianapolis
Indiana
Recruiting
University of Kansas Cancer Center
Westwood
Kansas
Recruiting
Luminis Health Radiation Oncology - Anne Arundel Health System
Annapolis
Missouri
Recruiting
University of Kansas Cancer Center - North
Kansas City
Missouri
Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit
Missouri
Recruiting
University of Kansas Cancer Center - Overland Park
Overland
Missouri
Recruiting
New York Cancer & Blood Specialists (NYCBS)
New Hyde Park
New York
Recruiting
New York Cancer & Blood Specialists (NYCBS)
New York
New York
Recruiting
University of Rochester Medical Center
Rochester
New York
Recruiting
New York Cancer & Blood Specialists (NYCBS)
Shirley
New York
Recruiting
New York Cancer & Blood Specialists (NYCBS)
The Bronx
New York
Recruiting
WakeMed Health & Hospitals
Cary
North Carolina
Recruiting
Abramson Cancer Center
Philadelphia
Pennsylvania
Recruiting
AHN Cancer Center
Pittsburgh
Pennsylvania
Recruiting
Old Parkland Hospital Hematology Oncology Clinic
Dallas
Texas
Recruiting
UT Southwestern Medical Center
Dallas
Texas
Recruiting
DHR Health Oncology Institute
Edinburg
Texas
Recruiting
Houston Methodist Cancer Center
Houston
Texas
Recruiting
Methodist Richardson Cancer Center
Richardson
Texas
Recruiting
Jason Bates at University of Texas Health Science Center
San Antonio
Texas
Recruiting
MultiCare Regional Cancer Center
Auburn
Washington
Recruiting
MultiCare Regional Cancer Center
Gig Harbor
Washington
Recruiting
MultiCare Regional Cancer Center
Puyallup
Washington
Recruiting
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane
Washington
Recruiting
MultiCare Institute for Research & Innovation
Tacoma
Washington
Recruiting
Universitaetsklinik fuer Innere Medizin V Innsbruck
Innsbruck
Austria
Recruiting
University Hospital Salzburg
Salzburg
Austria
Recruiting
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Vienna
Austria
Recruiting
+ 58 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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