RO7198457 & Atezolizumab vs Atezolizumab in ctDNA+ Stage II-III NSCLC
Research type
Research Study
Full title
A phase II, open-label, multicentre, randomized study of the efficacy and safety of RO7198457 in combination with atezolizumab versus atezolizumab alone following adjuvant platinum-doublet chemotherapy in patients who are ctDNA positive after surgical resection of stage II-III non-small cell lung cancer.
IRAS ID
279631
Contact name
Farah Louise Lim
Contact email
Sponsor organisation
Genentech Inc.
Eudract number
2019-003449-14
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Research Summary:
This research study will investigate the efficacy and safety of a new medicine called RO7198457 (which is a personalised cancer treatment) on patients who are circulating tumour DNA positive after surgical resection of Stage II-III non-small cell lung cancer.The goal of RO7198457 is to help train the immune system to recognise and attack cancer cells. Because the immune system has memory, it is hoped that once the immune cells have been trained, they will continue to work for a long time after the RO7198457 is given. This treatment is a type of gene therapy targeting unique mutations in a patient's tumour. Samples of the tumour tissue and blood will be collected and tested in order to see if RO7198457 can be manufactured for the patients.
The study will be conducted globally and approximately 80 patients will be randomised equally into one of two groups. In one group RO7198457 will be administered in combination with atezolizumab, which is an approved treatment for metastatic non-small cell lung cancer. In the other group atezolizumab alone will be administered. All patients must have circulating tumour DNA in their blood after surgical resection of Stage II-III non-small cell lung cancer and following standard-of-care adjuvant platinum-doublet chemotherapy.
The study consists of a three-part screening period, a treatment period, and a follow-up period. During the treatment part of the study, patients will have on site visits approximately every 4 weeks for 1 year in total. A number of assessments and procedures will be performed during the study including but not limited to physical examinations, blood sample tests and radiological assessments (MRI and/or CT/PET scans). These assessments are performed as part of the evaluation of the tumour and to determine if the study drug is effective and safe.
The study is sponsored by Genentech, Inc.
Lay summary of results:
Sponsor has advised that there will not be a Clinical Study Report as no patients were enrolled.REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0762
Date of REC Opinion
14 Jul 2020
REC opinion
Further Information Favourable Opinion