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

Titre officiel

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)

Sommaire:

L’étude vise à évaluer l'innocuité et l’efficacité du durvalumab en traitement néoadjuvant en association avec la chimiothérapie et l’oléclumab ou le monalizumab et d’un traitement adjuvant chez les participants atteints d’un cancer du poumon non à petites cellules résécable et de stade précoce.

Description de l'essai

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.

Voir cet essai sur ClinicalTrials.gov