RecruitingMetastatic Non-small Cell Lung Cancer

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

Eligible age

18+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: NovoCure GmbH

You may qualify if…

✓ ≥22 years of age in the USA
✓ ≥18 years of age outside of 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.
✓ ECOG Performance Status (PS) of 0-1.
✓ Adequate hematologic and end-organ function
✓ o For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants).

You may not qualify if…

✕ All individuals meeting any of the following exclusion criteria will be excluded from study participation:
✕ 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
✕ Received radiation therapy to the lung that is \> 30 Gy within 6 months of randomization.
✕ Has received prior radiotherapy within 2 weeks of randomization. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
✕ Is expected to require any other form of antineoplastic therapy while on study.