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HALT trial

Targeted therapy with or without dose intensified radiotHerapy for oligo-progressive disease in oncogene-Addicted Lung Tumours

Disease site: Advanced mutation positive non-small cell lung cancer (NSCLC)

Treatment modality: Stereotactic Body Radiotherapy (SBRT)

Status: Open

Trial details

HALT is a phase II/III, multicentre, randomised controlled trial in patients with advanced non-small cell lung cancer (NSCLC). Patients will have a defined, actionable mutation responding to targeted tyrosine kinase inhibitor (TKI) therapy and  3 or fewer sites of oligoprogressive disease, which will have developed after becoming resistant to targeted TKI treatment. 110 patients will be randomised to phase II of HALT with participants allocated to receive Stereotactic Body Radiotherapy at a 2:1 ratio (SBRT; 73 patients): (no SBRT 37 patients). All patients will continue to receive TKI therapy.

The phase II study aims to evaluate if the addition of SBRT to treat limited (≤ 3) sites of oligoprogressive disease with continuation of current TKI therapy improves progression-free survival outcomes in patients compared with continuation of TKI alone.

Transition to full phase III is dependent on feasibility and safety data obtained during the phase II study.

Further information

Chief Investigator: Dr Fiona McDonald (The Royal Marsden NHS Foundation Trust)

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: [email protected]

ISRCTN: ISRCTN53398136

Sponsor: The Institute of Cancer Research

Funding: Cancer Research UK (CRUK/16/020)

Further information is available at UK Clinical Trials Gateway

A plain English summary will be added once available.

Publications and presentations

McDonald F, Guckenberger M, Popat S, Andratschke N, Kilburn L, Toms C, Bliss J. HALT: targeted therapy beyond progression with or without dose-intensified radiotherapy in oligoprogressive disease in oncogene addicted lung tumours. Lung Cancer 2017; 103(Suppl. 1):S57. Poster presented at: 15th Annual British Thoracic Oncology Group Conference; 2017 Jan 25–27; Dublin, Ireland.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.