MEDI4736 in NSCLC (D4191C00003, ATLANTIC Study)
Research type
Research Study
Full title
A Phase II, Non-comparative, Open label, Multi-centre, International Study of MEDI4736, in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) who have received at least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen (ATLANTIC)
IRAS ID
152414
Contact name
Peter Schmid
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2013-005427-16
Clinicaltrials.gov Identifier
Research summary
This study is a Phase II, non-comparative, open label, multi-centre study assessing the efficacy and safety of MEDI4736, the study drug, in the treatment of male and female patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB-IV) who have received at least two prior systemic treatment regimens including one platinum-based chemotherapy regimen.
Programmed death ligand 1 (PD-L1) is an antigen expressed on the T-cell, a type of white blood cell that plays a role in cell-mediated immunity. The normal function of PD-L1 is to regulate the balance between T-cell activation and tolerance through interaction with two receptors, programmed death 1 (PD-1, CD279) and CD80 (B7-1). However, PD-L1 is expressed in a broad range of cancers with a high frequency. Furthermore, expression of PDL1 in cancers can lead to suppression of the immuneresponse.
MEDI4736 is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass which binds with high affinity and specificity to human programmed death ligand 1 (PD-L1). It is believed that this will block negative regulatory signals to T-cells, helping the immune system to respond to the lung cancer and prevent or slow it progressing. Indeed, substantial anti-tumour activity has been seen with similar agents.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/0680
Date of REC Opinion
10 Jun 2014
REC opinion
Further Information Favourable Opinion