Clinical Trials

14/002 NIVORAD

NIVORAD – A randomised phase 2 trial of nivolumab and stereotactic ablative body radiotherapy in advanced non-small cell lung cancer, progressing after first or second line chemotherapy.

Recruitment target:
50
(Final recruitment number)
Status:
Published
(Closed to recruitment: 7/6/19)

Summary:

The aim of this clinical trial is to determine the activity and safety of treating a site of disease with a single fraction of SABR during immunotherapy with nivolumab in advanced NSCLC progressing after 1 or 2 lines of chemotherapy.

Participants will be randomly allocated in a ratio of 2:1 to either nivolumab 240mg every 2 weeks plus SABR (experimental) or nivolumab 240mg every 2 weeks alone (control). Nivolumab is continued until disease progression or prohibitive toxicity.

Participants will be assessed regularly for treatment response and side effects during the treatment and follow up phase. Clinical assessments will be performed before each cycle of nivolumab (2 weekly) and CT scans at baseline, week 6, 12, 18, 24 then 12 weekly until progression. Anticancer treatments and survival will be reviewed every 12 weeks after progression. This will enable us to determine the activity and safety of each treatment option in patients with an asymptomatic metastasis.

Clinical trial design:

Randomised, controlled open-label clinical trial

Indication:

Advanced non-small cell lung cancer, progressing after first of second line chemotherapy.

Intervention:

A single fraction of SABR between days 8-14 of nivolumab cycle 1. All patients will receive Nivolumab (immunotherapy) 240mg (iv infusion) every 2 weeks.

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