LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovoCure GmbH
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥22 years of age in 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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
NovoTTF-200T
DeviceThe 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
DrugPembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
Platinum based chemotherapy
DrugPlatinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer
Treatment groups
734 Participants
are divided into 2 treatment groupsGroup A: Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based ChemotherapyExperimental treatment 3 interventions
Group B: Arm 2: Pembrolizumab and Platinum-based ChemotherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 years2
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 yearsSecondary outcomes
1
Progression Free Survival (PFS)
Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to histology.
Time frame
up to 6 years2
Overall Survival (OS)
Overall Survival (OS) in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to histology.
Time frame
up to 6 years3
Progression Free Survival (PFS)
PFS per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to PD-L1 Tumor Proportion Score (TPS).
Time frame
up to 6 years4
Overall Survival (OS)
OS in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to PD-L1 TPS.
Time frame
up to 6 yearsSponsors and contacts
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Source ClinicalTrials.gov