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.

 

Trial Summary:

Participants are 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. Following study treatment phase patients will be follow up 12 weekly until disease progression. Anticancer treatment and survival every 12 weeks after progression.

Supported By:

Bristol-Myers Squibb, TROG

Eligibility:

Adults with advanced non-small-cell lung cancer (NSCLC) progressing after 1 or 2 lines of chemotherapy and with an extra-pulmonary metastasis suitable for SABR. Tumour blocks must be available to test for PD-L1 expression.

Registration ID:

ACTRN 12616000352404

Participation:

ANZ

Australian Lead Group:

ALTG

Status:

Closed

Activation Date:

06/01/2017

Chairs:

Paul Micthell (Austin Health)

Contact:

nivorad.study@sydney.edu.au