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Trial Title:
LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)
NCT ID:
NCT06558799
Condition:
Non-Small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Conditions: Keywords:
NSCLC
Metastatic
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
NovoTTF-200T
Description:
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 exert electric forces intended to disrupt cancer cell
division and induce immunogenic cell death.
Arm group label:
NovoTTF-200T + Pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize
and attack cancer cells.
Arm group label:
NovoTTF-200T + Pembrolizumab
Summary:
The purpose of the study is to test the effectiveness and safety of TTFields therapy,
delivered using the NovoTTF-200T device, concomitant with pembrolizumab in subjects with
metastatic NSCLC previously treated with a PD-1/PD-L1 inhibitor and platinum-based
chemotherapy.
Criteria for eligibility:
Criteria:
INCLUSION CRITERIA:
- ≥18 years of age
- Histologically or cytologically confirmed diagnosis of NSCLC.
- Documented positive tumor PD-L1 expression (TPS≥1%).
- Eastern Cooperative Oncology Group (ECOG) Score of 0-1.
- Diagnosis of radiological progression while on or after first platinum-based
systemic therapy administered for advanced or metastatic disease.
- Subjects must have received one line of PD-1/PD-L1 inhibitor therapy for advanced or
metastatic NSCLC. PD-1/PD-L1 inhibitor may have been given alone or in combination
with other therapy.
- Subjects who received PD-1/PD-L1 inhibitor for advanced disease, must have had a
best response on PD-1/PD-L1 inhibitor of stable disease (SD), partial response (PR)
or complete response (CR).
- Subjects must have experienced disease progression more than 84 days following Cycle
1 Day 1 (C1D1) of their most recent PD-1/PD-L1 inhibitor therapy.
EXCLUSION CRITERIA - All individuals meeting any of the following exclusion criteria will
be excluded from study participation:
- Mixed small cell and NSCLC histology.
- Subject must not have leptomeningeal disease or spinal cord compression.
- Subject must not have untreated, symptomatic brain metastases, or residual
neurological dysfunction.
- Subjects must not have received more than one line of PD-1/PD-L1 inhibitor for
advanced disease.
- Subjects with a known sensitizing mutation for which the Food and Drug
Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK,
ROS1) are excluded unless previously received at least one of the approved
therapy(ies).
- Subjects with more than 2 lines of therapy in the advanced setting.
- Pregnant or breastfeeding.
- Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper
torso.
- Known allergies to medical adhesives or hydrogel.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinik f. Innere Medizin III
Address:
City:
Salzburg
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Richard Greil
Phone:
004 357 255 25800
Email:
r.greil@salk.at
Start date:
October 14, 2024
Completion date:
October 2026
Lead sponsor:
Agency:
NovoCure GmbH
Agency class:
Industry
Source:
NovoCure Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06558799
