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Related Experiment Video

Updated: Dec 9, 2025

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Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer:

David M Waterhouse1, Edward B Garon2, Jason Chandler3

  • 1The US Oncology Network/Oncology Hematology Care, Cincinnati, OH.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|September 10, 2020
PubMed
Summary

Continuing nivolumab immunotherapy beyond one year significantly improves progression-free survival and overall survival in advanced non-small-cell lung cancer patients. This fixed-duration approach demonstrated superior efficacy and a comparable safety profile compared to continuous therapy.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Clinical Trials

Background:

  • Limited data exist on optimal immunotherapy duration for non-small-cell lung cancer (NSCLC).
  • Understanding treatment duration is crucial for maximizing patient benefit and managing resources.

Purpose of the Study:

  • To evaluate the impact of 1-year fixed-duration versus continuous nivolumab therapy.
  • To assess efficacy and safety in previously treated advanced NSCLC patients.

Main Methods:

  • Exploratory analysis of the phase IIIb/IV CheckMate 153 study.
  • Randomized patients receiving nivolumab monotherapy at 1 year to either continuous treatment or 1-year fixed-duration with optional retreatment.
  • Compared outcomes in intent-to-treat (ITT) and progression-free survival (PFS) populations.

Main Results:

  • Median PFS was significantly longer with continuous nivolumab (24.7 months) versus 1-year fixed-duration (9.4 months) in the PFS population (HR, 0.56).
  • Median overall survival from random assignment was longer with continuous therapy in both PFS (not reached vs. 32.5 months) and ITT (not reached vs. 28.8 months) populations.
  • No new safety signals were identified, with few new-onset treatment-related adverse events.

Conclusions:

  • Continuing nivolumab beyond 1 year in previously treated advanced NSCLC improves outcomes.
  • These findings represent the first randomized data comparing continuous versus fixed-duration immunotherapy in this setting.