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Poster Display session 1

2176 - IFCT-1701 DICIPLE: a randomized phase 3 trial comparing continuation Nivolumab-Ipilimumab doublet immunotherapy until progression versus observation in patients with PDL1-positive stage IV Non-Small Cell Lung Cancer (NSCLC) after Nivolumab-Ipilimumab induction treatment

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Gerard Zalcman

Citation

Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260

Authors

G. Zalcman1, A.C. Toffart2, A. Madroszyk Flandin3, O. Molinier4, C. Dayen5, T. Egenod6, A. Dixmier7, E. Giroux Leprieur8, P. Masson9, N. Cloarec10, L. Thibonnier11, L. Favier12, D. Debieuvre13, J. Mazieres14, S. Van Hulst15, E. Pichon16, E. Amour17, F. Morin17, P. Souquet18

Author affiliations

  • 1 Thoracic Oncology, AP-HP Hopital Bichat Claude Bernard, 75018 - Paris/FR
  • 2 Thoracic Oncology, CHU de Grenoble-Alpes- Le site nord à La Tronche - Hopital Michallon, 38700 - La Tronche/FR
  • 3 -, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 4 Pneumology, Centre Hospitalier Du Mans, 72037 - Le Mans/FR
  • 5 Pneumology, CH, 75009 - Saint-Quentin/FR
  • 6 Pneumology, CHU Limoges - Hopital Dupuytren, 87042 - Limoges/FR
  • 7 Pneumology, C.H.R. Orleans - La Source, 45100 - Orleans/FR
  • 8 Pneumology, AP-HP Hopital Ambroise Pare, 92100 - Boulogne-Billancourt/FR
  • 9 Pneumology, CH Cholet, 49 - Cholet/FR
  • 10 Pneumology, CH, Avignon/FR
  • 11 Pneumology, Hôpital Gabriel Montpied, Clermont-Ferrand/FR
  • 12 Oncology, CLCC, Dijon/FR
  • 13 Pneumology, Hopital Emile Muller, 68100 - Mulhouse/FR
  • 14 Thoracic Oncology, Hospital Larrey, 31400 - Toulouse/FR
  • 15 Pneumology, CHU Nimes, Caremeau, 30029 - Nimes/FR
  • 16 Pneumology, CHRU Bretonneau, 37044 - Tours/FR
  • 17 Clinical Research Unit, IFCT, 75009 - PARIS/FR
  • 18 Thoracic Oncology, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR

Resources

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Abstract 2176

Background

We raise the hypothesis that a STOP and GO strategy with induction by double immunotherapy Nivolumab + Ipilimumab combination during 6 months, followed by observation in patients with disease control (DC) at 6 months, would not be inferior to immunotherapy combination continuation until progression or unacceptable toxicity, in terms of progression-free survival, allowing lower toxicities cumulative rates, better quality of life and lower costs. Such strategy should not penalize overall survival, provided resuming immunotherapy at disease progression before second-line platinum-based chemotherapy.

Trial design

This is an open-label, randomized, phase III study in adult (≥18 years) patients, with stage IV non-small cell lung cancer, PD-L1 positive tumors, previously untreated for advanced disease. Subjects will first be locally assessed for PD-L1 expression, using 1% cut-off. Patients with enough tumor samples for central PD-L1 expression assessment, will be given first-line Nivolumab+Ipilumumab combination as followed: Nivolumab administered IV over 30 minutes at 3 mg/kg every 2 weeks combined with Ipilimumab administered IV over 30 minutes at 1 mg/kg every 6 weeks.

Only patients with DC (objective response or stable disease), confirmed at 6 months, after a 1rst tumor evaluation at 3 months or beyond in case of pseudo-progression needing tumor reassessment, and without drug-related toxicity commanding treatment discontinuation will be randomized 1:1 either to continuation of Nivolumab+Ipilumumab combination until disease progression or unacceptable toxicity, or to clinical and radiological observation from week 24.

Subjects receiving Nivolumab+Ipilimumab beyond investigator assessed progression must also continue tumor assessments until treatment discontinuation.

Enrollment will end after approximately 868 subjects have been randomized (25/months). The primary endpoint of the study is Progression-Free Survival.

Clinical trial identification

NCT03469960.

Editorial acknowledgement

Legal entity responsible for the study

IFCT (French Cooperative Thoracic Intergroup).

Funding

Bristol-Myers Squibb.

Disclosure

All authors have declared no conflicts of interest.

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