A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

Official Title

A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

Summary:

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

Trial Description

Primary Outcome:

• Progression Free Surival (PFS)

• Overall Survival (OS)
• Objective response rate (ORR)
• Overall survival (OS) at 24 months
• Duration of response (DoR)
• Progression free survival (PFS) at 6, 12, 18, and 24 months
• Time from randomization to second progression (PFS2)
• Time from randomization to first date of distant metastasis or death (TTDM)
• Time from randomization to start date of first subsequent therapy (TFST)
• Progression free survival (PFS) as assessed by Investigator
• IHC analysis of PD-L1 TC expression
• Concentration of Durvalumab
• Anti-drug antibodies (ADAs)
• Time to deterioration in pulmonary symptoms (TTFCD)
• Concentration of Oleclumab
• Concentration of Monalizumab

View this trial on ClinicalTrials.gov