BR.31 : A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Systemic therapy | LungLung,Non-Small Cell Lung Cancer,

Trial Overview Read MoreRead more

This phase III trial is trying to determine whether it is better to receive a new drug (MEDI4736) after surgery for Lung Cancer, or if it is better to have no further treatment.
 

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

Other Non-Commercial Sponsor

National Health & Medical Research Council (NHMRC)

Summary

BR.31 a clinical research study that is testing MEDI4736, a new type of drug for the treatment of non-small cell lung cancer (NSCLC) that was completely removed with surgery. It is being led by the Australasian Lung Cancer Trials Group (ALTG) and coordinated by the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC). The purpose of this study is to find out whether it is better to receive the new drug, MEDI4736, or no further treatment after surgery (and possibly chemotherapy) for lung cancer. The study involves randomly allocating participants to receive treatment with either MEDI4736 or placebo, a substance that has no active medicine in it. Two-thirds (2/3) of the participants in this study will receive MEDI4736 and the other third (1/3) will receive placebo. Participants will be required to receive intravenous infusions of MEDI4736 or placebo at 10mg/kg every 2 weeks for 6 months followed by intravenous infusions of MEDI4736 or placebo at 20mg/kg every 4 weeks for 6 months. Participants will then be followed up for a maximum of 10 years to assess overall survival and disease free survival.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Epworth Hospital
Richmond
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055

Monash Medical Centre, Medical Oncology
Clayton
Ms Irina Arzhintar
Irina.Arzhintar@monashhealth.org
03 8572 2018

Peninsula & South Eastern Haematology and Oncology Group
Frankston
Mr Albert Goikman
ag@paso.com.au
03 9771 8918

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9288 3167