71TiP - A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after res...

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Non-small-cell lung cancer
Immunotherapy
Thoracic malignancies
Therapy
Presenter Luis Paz-Ares
Citation Annals of Oncology (2017) 28 (suppl_2): ii20-ii23. 10.1093/annonc/mdx085
Authors L. Paz-Ares1, B. Hasan2, U. Dafni3, J. Menis4, E. De Maio4, K. Oselin5, I. Albert6, M. Faehling7, P. Van Schil8, M.E.R. O'Brien9
  • 1Hospital Universitario Doce de Octubre, 28041 - Madrid/ES
  • 2EORTC HQ, 1200 - Brussels/BE
  • 3University of Athens & Frontier Science Foundation, Athens/GR
  • 4European Organisation for Research and Treatment (EORTC)-HQ, 1200 - Brussels/BE
  • 5North Estonia Medical Centre, Tallinn/EE
  • 6Matrai Gyogyintezet, Matrahaza/HU
  • 7Staedtische Kliniken, Esslingen/DE
  • 8University of Antwerp, Antwerp/BE
  • 9Royal Marsden Hospital, SW3 6JJ - Sutton/GB

Abstract

Background

In the last 5 years no major advances have been made in the treatment of early stage NSCLC. Checkpoint inhibitors have shown promising clinical efficacy in advanced, refractory non-small cell lung cancer (NSCLC), but they have not yet been explored in the adjuvant setting. PEARLS (NCT02504372) is international, triple-blinded, placebo-controlled, randomized phase III trial to compare pembrolizumab versus placebo after complete resection of stage IB (T ≥ 4 cm), II and IIIA NSCLC, followed by standard adjuvant chemotherapy, if appropriate as per local guidelines, in patients who have signed the informed consent.

Trial design

Eligible patients are those with completely resected stage IB (T ≥ 4 cm), II and IIIA NSCLC that have or have not received adjuvant platinum-based chemotherapy and whose PD-L1 status is known: negative (TPS=0%) versus weak positive (TPS = 1-49%) versus strong positive (TPS≥50%). Co-primary endpoints are disease-free survival in the PD-L1 strong positive subgroup and in the overall population. An HR = 0.78 is targeted for the whole population with 640 disease free survival events from a sample size of 1380 randomized patients. Secondary endpoints include disease-free survival in the PD-L1 positive subgroup, overall survival in each subpopulation and in the overall population, lung cancer specific survival, and safety and tolerability. The exploratory endpoints will assess pharmacokinetics, immunogenicity, quality of life and potential biomarkers of treatment response. Recruitment started in January 2016 and is currently ongoing. As of November 17, 2016, among the 102 randomized patients so far, 44 (43.1%), 32 (31.4%) and 26 (25.5%) patients have negative, weak positive and strong positive PD-L1 status respectively.

Clinical trial identification

(EudraCT number 2015-000575-27) (NCT02504372)

Legal entity responsible for the study

MSD EORTC, ETOP

Funding

MSD

Disclosure

All authors have declared no conflicts of interest.