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
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
Study locations (35)
Central Alabama Research
Birmingham, Alabama, 35209
Western Regional Medical Center, LLC
Goodyear, Arizona, 85338
St. Jude Herritage Medical Group
Fullerton, California, 92835
Hoag Family Cancer Institute - Hoag Memorial Hospital
Newport Beach, California, 92663
Sutter Institute for Medical Research
Sacramento, California, 95816
Florida Cancer Affiliates - Ocala Oncology
Ocala, Florida, 34474
Moffitt Cancer Center
Tampa, Florida, 33612
Northwest Oncology & Hematology
Barrington, Illinois, 60010
Elmhurst Hospital Nancy Knowles Cancer Center
Elmhurst, Illinois, 60126
Edward Cancer Center
Naperville, Illinois, 60540-6766
Cancer Treatment Centers of America (CTCA)
Zion, Illinois, 60099
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
University of Kansas Cancer Center
Westwood, Kansas, 66205
Luminis Health Radiation Oncology - Anne Arundel Health System
Annapolis, Missouri, 21401
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
University of Kansas Cancer Center - Overland Park
Overland, Missouri, 66210
New York Cancer & Blood Specialists (NYCBS)
New Hyde Park, New York, 11042
New York Cancer & Blood Specialists (NYCBS)
New York, New York, 10028
University of Rochester Medical Center
Rochester, New York, 14642
New York Cancer & Blood Specialists (NYCBS)
Shirley, New York, 19967
New York Cancer & Blood Specialists (NYCBS)
The Bronx, New York, 10469
WakeMed Health & Hospitals
Cary, North Carolina, 27518
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
AHN Cancer Center
Pittsburgh, Pennsylvania, 15212
Old Parkland Hospital Hematology Oncology Clinic
Dallas, Texas, 75235
UT Southwestern Medical Center
Dallas, Texas, 75235
DHR Health Oncology Institute
Edinburg, Texas, 78539
Methodist Richardson Cancer Center
Richardson, Texas, 75082
Jason Bates at University of Texas Health Science Center
San Antonio, Texas, 78229
MultiCare Regional Cancer Center
Auburn, Washington, 98001
MultiCare Regional Cancer Center
Gig Harbor, Washington, 98335
MultiCare Regional Cancer Center
Puyallup, Washington, 98372
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, 99218
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405