Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216301
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-12-29
Brief Title:
LUNAR-2 TTFields With Pembrolizumab Platinum-based Chemotherapy for Metastatic NSCLC
Sponsor:
NovoCure GmbH
Organization:
NovoCure Ltd
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUNAR-2
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
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 v11
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 TPS 1-49 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
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 v11
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 TPS 1-49 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None