iSABRT : Randomized Phase I/II Study of Ablative Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early-Stage Non-Small Cell Lung Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

One/TwoPhase One/Two

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Multiple treatment types,Radiotherapy,Systemic therapy | LungNon-Small Cell Lung Cancer

Trial Overview Read MoreRead more

This phase I/II trial is evaluating the benefits of using a targeted therapy (Durvalumab) in combination with Stereotactic Ablative Body Radiotherapy (SABR) to treat inoperable early-stage non-small-cell lung cancer.
 

This trial is treating patients with inoperable early-stage non-small-cell lung cancer.

This is a systemic therapy and radiotherapy.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • 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 had certain treatments, surgical procedures or drugs.

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

Randomized Phase I/II Study of Ablative Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early-Stage Non-Small Cell Lung Cancer

Commercial Sponsor

AstraZeneca

Summary

Initially, 15 eligible patients will receive both intravenously administered Durvalumab and Stereo Ablative Body Radiotherapy (SABR) to assess the safety of the therapies in combination. After the initial safety test eligible patients will either receive both Durvalumab and SABR, or SABR alone. SABR will be administered on Day 0 over a number of fractions (3,4 or 10) with total doses of either 54, 50 or 65 Grays. Durvalumab will be intravenously administered five days before the SABR and on Day 23, then once every 4 weeks. Follow-up CT imaging will be performed 12 weeks post the administration of SABR, with routine CT scans performed as per standard care thereafter.

Recruiting Hospitals Read MoreRead more

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

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next