Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

Official Title

A Phase II Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIA) Non-small Cell Lung Cancer (NeoCOAST 2)

Summary:

The study is intended to assess the safety and efficacy of neoadjuvant Durvalumab in combination with chemotherapy and Oleclumab or Monalizumab and adjuvant treatment in participants with resectable, early-stage non-small cell lung cancer

Trial Description

Primary Outcome:

• Number of participants with pathological complete response (pCR)
• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome:

• Number of participants experiencing an event-free survival (EFS) event
• Number of participants experiencing a disease-free survival (DFS) event
• Number of participants having surgical resection
• Number of participants with major pathological response (mPR)
• Number of participants with Objective response rate (ORR)
• Overall survival (OS)
• Serum concentration of study drugs (Durvalumab/Oleclumab/Monalizumab)
• Number of participants with anti-study drug antibodies (ADA)
• Baseline PD-L1 expression
• Changes in circulating tumour DNA (ctDNA)

In this open-label, 2-arms study, eligible participants will be enrolled and randomised in a 1:1 ratio to receive either Durvalumab + chemotherapy + Oleclumab before surgery followed by Durvalumab + Oleclumab post-surgery (Arm 1) or Durvalumab + chemotherapy + Monalizumab before surgery followed by Durvalumab + Monalizumab post-surgery (Arm 2). Surgical resection is to be performed approximately within 40 days from the last dose of neoadjuvant treatment.

View this trial on ClinicalTrials.gov