Blockade of the PD-1 pathway is the mainstay for the first-line (1L) treatment of patients (pts) with advanced NSCLC without targetable oncogenic alterations. Cemiplimab is a PD-1 inhibitor and has improved overall survival (OS) and progression-free survival (PFS) vs chemotherapy in 1L advanced NSCLC patients with high PD-L1 expression (PD-L1 ≥50%) who are without driver mutations based on the EMPOWER-Lung 1 study. Cemiplimab was subsequently licensed as monotherapy in this front line pt population by the FDA (Feb 2021) and EMA (May 2021) based on results from EMPOWER-Lung 1. Currently, there are no prospective data on the effectiveness and safety of cemiplimab in advanced NSCLC within routine clinical practice setting. Such data could provide additional evidence to guide treatment and optimal use as per the licensed indication, including in patients that could have been excluded or not typically included in clinical trials. Therefore, CEMI-LUNG (NCT05363319) is a pragmatic, prospective, noninterventional, observational cohort study that aims to address these data gaps.
Pts with advanced NSCLC who are initiating a licensed cemiplimab-based regimen as part of their routine clinical practice are eligible. Study visits will follow the standard-of-care schedule and data will be collected every 3 months while on treatment and every 6 months for 36 months following treatment discontinuation (maximum study duration, 72 months) until death, loss to follow-up, study withdrawal or end of study period, whichever occurs first. The study plans to enrol ∼300 pts across 30 European sites. Decisions regarding treatment will be made by the treating physician in accordance with local clinical practice. The primary objective is to assess overall survival. Secondary objectives are to describe objective response rate, time to response, time to first subsequent anti-NSCLC treatment, duration of response, PFS, and the incidence and severity of adverse events. Three interim analyses are planned in addition to the final analysis. This study is open for enrolment.
NCT05363319.
Editorial writing support was provided by Sameen Yousaf, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi.
Sanofi and Regeneron Pharmaceuticals, Inc.
Sanofi and Regeneron Pharmaceuticals, Inc.
C. Gessner: Financial Interests, Personal, Advisory Board: GlaxoSmithKline, Pfizer, AstraZeneca, Roche, Novartis, Bristol-Myers Squibb, Merck Sharp & Dohme, Berlin-Chemie, Chiesi, Boehringer Ingelheim and Sanofi. F. Griesinger: Financial Interests, Personal, Other, Scientific support: Astra, Boehringer, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Siemens, Sanofi; Financial Interests, Personal, Speaker’s Bureau: Astra, Boehringer, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Siemens, Tesaro/GSK, Amgen, Sanofi; Financial Interests, Personal, Advisory Board: Astra, Boehringer, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Tesaro/GSK, Siemens, Tesaro, Amgen, Sanofi. R. Shah: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, AstraZeneca, Roche, BMS, MSD, Pfizer, Lilly, Novartis, Takeda, Bayer, Beigene, Guardant, Sanofi. T. Talbot: Financial Interests, Personal, Advisory Board: AbbVie, Amgen Boerhinger Ingelheim, Bristol-Myers Squibb, Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Roche and Sanofi-Genzyme. S. Venkateshan: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. A.K. Vadanahalli Shankar: Financial Interests, Personal, Stocks/Shares: Sanofi; Financial Interests, Personal, Full or part-time Employment: Sanofi. A. Seluzhytsky: Financial Interests, Personal, Stocks/Shares: Sanofi; Financial Interests, Personal, Full or part-time Employment: Sanofi. D.M. Marsden: Financial Interests, Personal, Stocks/Shares: Sanofi; Financial Interests, Personal, Full or part-time Employment: Sanofi.