Pneumologische Onkologie Tumor Treating Fields (TTFields) therapy with standard systemic therapy in metastatic non-small cell lung cancer following progression on or after platinum-based therapy: global randomized, pivotal (phase 3) LUNAR study

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Background : TTFields are electric fields that disrupt cancer cell viability. TTFields therapy is approved for glioblastoma and mesothelioma. The randomized, pivotal (phase 3) LUNAR study (NCT02973789) assessed the efficacy and safety of TTFields therapy with investigator’s choice of standard systemic therapy (ST; immune checkpoint inhibitor [ICI] or docetaxel [DTX], standard of care at time of study design) for metastatic non-small cell lung cancer (mNSCLC) progressing on/after platinum-based therapy. Methods : Adult patients were randomized 1:1 to TTFields+ST or ST. Primary endpoint: overall survival (OS); key secondary endpoints: OS in ICI and DTX subgroups; other secondary endpoints: adverse events (AEs) and patient-reported HRQoL assessed from baseline to 54 weeks by the validated EORTC QLQ-C30 questionnaire. Results: 276 patients (TTFields+ST, n=137; ST, n=139) were included. Median (m) age was 64 years (range, 22– 86), 64% were male, 57% had non-squamous NSCLC, 96% had ECOG PS 0–1, 10% had >1 prior line of ST, and 32% had prior ICI. Characteristics were balanced between arms. OS was significantly extended with TTFields+ST vs ST: mOS (95% CI) 13.2 (10.3–15.5) vs 9.9 (8.1–11.5) months (mo); HR 0.74 (95% CI 0.56–0.98); P=0.035. In the ICI subgroup (n=134), TTFields therapy significantly improved OS vs ICI alone: mOS (95% CI) 18.5 (10.6–30.3) vs 10.8 (8.2–18.4) mo; HR 0.63 (95% CI 0.41–0.96); P=0.030. In the DTX subgroup (n=142), mOS (95% CI) with TTFields+DTX vs DTX was 11.1 (8.2–14.1) vs 8.7 (6.3–11.3) mo; HR 0.81 (95% CI 0.55–1.19); P=0.28. AEs were similar for TTFields+ST (97%) vs ST (91%). 71% reported a device-related AE; most were dermatological, and 6% were grade 3. For global health status, there was no clinically meaningful (≥10 points) decline in either treatment group, or difference between treatment groups. Discussion: TTFields therapy plus ST extended OS vs ST without exacerbating systemic toxicities or adversely affecting HRQoL in patients with mNSCLC progressing on/after platinum-based therapy. Conclusion: These results warrant TTFields therapy as an option to manage mNSCLC in this setting. Publication History Article published online: 01 March 2024 © 2024. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany

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