397TiP - Phase III LUNAR study: Tumor treating fields (TTFields) with standard of care for the treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure

Background

Tumor Treating Fields (TTFields) therapy is a novel, loco-regional treatment modality approved for use in glioblastoma and malignant pleural mesothelioma. TTFields are electric fields generated by a portable, wearable device, and delivered to the tumor via arrays placed on the skin. TTFields act by disrupting cellular processes critical for cancer cell viability and tumor progression. Preclinical data demonstrated efficacy of TTFields with either chemotherapy or immunotherapy in non-small cell lung cancer (NSCLC), in vitro and in vivo. Results from the EF-15 pilot study of TTFields therapy with pemetrexed in NSCLC showed good efficacy and tolerability, and provided rationale for further investigation in a phase 3 setting.

Trial design

LUNAR (EF-24; NCT02973789) is a phase 3, randomized, open-label study that enrolled adult patients (pts) ≥ 22 yrs, with ECOG PS ≤ 2, and histologically confirmed squamous/non-squamous, unresectable, stage 4 NSCLC which had progressed after platinum therapy. Pts were randomized 1:1 to receive TTFields (150 kHz) therapy (generated by the NovoTTF-200T device) for ≥ 18 h with standard of care (SOC; immune checkpoint inhibitor or docetaxel) or SOC alone. Follow-up is every 6 wks, and treatment will continue until disease progression, intolerable toxicity or withdrawal of consent. Primary endpoint is OS; secondary endpoints include PFS, ORR, QOL and safety. The device manufacturer will provide technical and lifestyle integration training for pts and caregivers, as well as guidance on preventing and managing skin adverse events in line with published guidance, by means of Device Support Specialists, field personnel, and various information resources. Usage information from the device is provided to pts and physicians to aid discussions and optimize outcomes by maximizing usage. This novel support framework empowers pts to confidently operate the NovoTTF-200T System, ensuring TTFields therapy is easily integrated into everyday life, increasing likelihood of high usage, and ultimately optimizing outcomes.

Clinical trial identification

NCT02973789.

Legal entity responsible for the study

Novocure.

Funding

Novocure.

Disclosure

T.A. Leal: Financial Interests, Personal, Advisory Board: Blueprint, Merck, AstraZeneca, Jazz, Boehringer Ingelheim, Mrati; Financial Interests, Personal, Other, Consulting: Jazz, Boehringer Ingelheim, Lilly, Janssen, Amgen. C.C. Pichardo: Financial Interests, Personal, Full or part-time Employment: Novocure; Financial Interests, Personal, Stocks/Shares: Novocure. J.P. Ward: Non-Financial Interests, Personal, Advisory Board: Takeda; Non-Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Institutional, Funding: Instil, Harpoon, Pfizer, Genmab. All other authors have declared no conflicts of interest.