A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

Titre officiel

A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer

Sommaire:

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Description de l'essai

Primary Outcome:

  • Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)
Secondary Outcome:
  • Overall Survival (OS)
  • Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR)
  • Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review
  • Incidence of Serious Adverse Events (SAEs)
  • Incidence of Adverse Events (AEs)

Voir cet essai sur ClinicalTrials.gov

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Ressources

Société canadienne du cancer

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