Informations générales (source: ClinicalTrials.gov)
LUNAR-4: Pilot, Single Arm, Open-Label, Multinational Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for the Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a PD-1/PD-L1 Inhibitor and Platinum-Based Chemotherapy (LUNAR-4)
Interventional
Phase 2
NovoCure GmbH (Voir sur ClinicalTrials)
octobre 2024
décembre 2026
10 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos Chouai | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP - Hôpital Ambroise-Paré - 92100 - Boulogne-Billancourt - France | Etienne GIROUX-LEPRIEUR | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Intercommunal de Cornouaille Service D'oncologie Médicale - 29107 - Quimper - France | Romain Corre | Contact (sur clinicalTrials) | |||
| Centre Léon Berard Service D'oncologie Médicale - 69373 - Lyon - France | Maurice Perol | Contact (sur clinicalTrials) | |||
| Hôpital Européen Marseille - 13003 - Marseille - France | Remi Bonetto | Contact (sur clinicalTrials) | |||
| Hôpital Privé du Confluent Service D'oncologie Médicale - 44277 - Nantes - France | Cyriac Blonz | Contact (sur clinicalTrials) | |||
| Montpellier University Hospital - 34295 - Montpellier - France | Benoît Roch | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- ≥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.