SAFFRON
Research type
Research Study
Full title
A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON)
IRAS ID
1005139
Contact name
Agathe Cabarrot
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-006374-24
Clinicaltrials.gov Identifier
Research summary
This study is to learn more about an experimental drug called Savolitinib for people over 18 with non-small cell lung cancer (NSCLC) that has progressed whilst already being treated with a drug called Osimertinib, and also have a tumour sample that has tested positive for mesenchymal epithelial transition (MET).
Osimertinib is known to work well initially but can become less effective after several months, so this study will find out if administering Savolitinib in combination with Osimertinib will be effective for people with NSCLC. Both Osimertinib and Savolitinib work to block the action of abnormal proteins that signal cancer cells to multiply.
In the study an equal number of participants will receive either Savolitinib in combination with Osimertinib or standard chemo therapy. About 324 participants will take part in this study globally. In the UK the study will be carried out at NHS and Private organisations. Participants will be in the study for approximately 12 months and the study will involve 20 visits to the participating site. Participants must also be willing to stop taking some medications that may interact with the study drugs.
There are 2 screening visits, part 1 will confirm the participants’ tumour is MET positive and part 2 will confirm the participant meets all the requirements to participate in the study. During the treatment period of the study there will be 3 visits during the first cycle of treatment and then 1 visit per cycle until treatment has finished, after which there will be a 28 day follow up visit.
The study will also involve the following tests and procedures:
Blood tests, CT, MRI and Echocardiogram or MUGA scans, Electrocardiograms (ECG), Questionnaires, Physical examinations and Genetic analysis.Participants must give their consent to join the study and agree their GP will be informed of their participation.
REC name
Wales REC 5
REC reference
22/WA/0107
Date of REC Opinion
26 May 2022
REC opinion
Further Information Favourable Opinion