A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non-small cell lung cancer.

See ANZCTR for full trial details >

 

Trial Summary:

This study looks at the effectiveness of adjuvant therapy with MEDI4736 in patients with completely resected non-small cell lung cancer. MEDI4736 is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour's immune-evading tactics. Participants will be randomised to receive treatment with either MEDI4736 or placebo. Two-thirds of the participants in this study will receive MEDI4736 and the other third will receive placebo. Participants will receive intravenous infusions of MEDI4736 or placebo every 4 weeks for 12 months (up to 13 infusions). Participants will then be followed for approximately 10 years to assess overall survival and disease free survival.

Supported By:

Canadian Cancer Trial Group (CCTG), Astra Zeneca

Eligibility:

 

Registration ID:

ACTRN12615000323527

Participation:

International

Australian Lead Group:

TOGA

Status:

In follow-up

Activation Date:

July 2015

Chairs:

Glenwood Goss (Intl.), Sue-Anne McLachlan (ANZ)

Contact:

BR.31.study@sydney.edu.au