GO41892: Atezolizumab and Cabozantinib vs Docetaxel alone in NSCLC
Research type
Research Study
Full title
A PHASE III, MULTICENTRE, RANDOMISED, OPEN-LABEL, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS DOCETAXEL MONOTHERAPY IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER PREVIOUSLY TREATED WITH AN ANTI-PD L1/PD-1 ANTIBODY AND PLATINUM CONTAINING CHEMOTHERAPY
IRAS ID
283871
Contact name
Tom Newsom-Davis
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-000100-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Lung cancer remains the leading cause of cancer deaths worldwide. Approximately 85% of patients with lung cancer have a type called non-small cell lung cancer (NSCLC).
The overall 5-year survival rate for NSCLC is 23% but drops to as low as 6% for metastatic NSCLC (has grown or spread).There is a significant unmet need in patients with metastatic NSCLC whose disease has worsened following prior treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody (a type of immunotherapy) either in combination or in succession.
Currently, single-agent chemotherapy is the main treatment option available to these patients but this has modest activity. Both atezolizumab and cabozantinib have shown single-agent activity in multiple tumour types, including NSCLC. Moreover, atezolizumab is approved as monotherapy for patients with metastatic NSCLC whose disease has worsened during or following platinum-containing chemotherapy, or as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy.
This study will compare the effects of atezolizumab plus cabozantinib versus docetaxel on patients with metastatic NSCLC, whose disease has worsened during or after receiving an anti-PD-L1/PD-1 antibody and a platinum-containing chemotherapy. The encouraging observed clinical activity and tolerability of the combination of atezolizumab and cabozantinib holds promise as a potential new treatment opportunity in this patient population.
There will be approximately 30 patients recruited at 10 UK sites.
The study is sponsored by F. Hoffmann-La Roche.
Research Summary; Version 1, dated 27-May-2020
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0200
Date of REC Opinion
25 Sep 2020
REC opinion
Further Information Favourable Opinion