Do you have Non-Small Cell Lung Cancer that did not respond or stopped responding to osimertinib treatment?

Background

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. There are a number of types of treatment for NSCLC, including surgery, chemotherapy, radiotherapy and targeted therapy.

Osimertinib is a targeted therapy that has been shown to slow the growth of NSCLC tumours that are positive for a gene known as epidermal growth factor receptor (EGFR+). Osimertinib is given to patients if their test results show that their cancer cells have a change in the EGFR gene.

In some cases, presence of increased copies of a gene called MET or increased MET protein expression can stop osimertinib treatment from working. This study will investigate a combination of osimertinib with a new experimental drug, savolitinib, in people with EGFR+ NSCLC for whom osimertinib treatment alone did not work.

About the Study

The SAFFRON study will investigate the safety and efficacy of a new combination of treatments in people with EGFR+ NSCLC whose tumours have not responded to or stopped responding to osimertinib treatment.

If you take part in this study, you will be randomly placed in one of two treatment groups, and you will know which group you are in:

• The savolitinib plus osimertinib group will take savolitinib and osimertinib tablets every day.
• The chemotherapy group will receive platinum-based doublet chemotherapy. This treatment is given intravenously and will be administered at the study centre every 3 weeks.

During the study, both groups will have regular visits to the study center. At these visits you will receive a health check-up, talk to the study investigators, and undergo some blood tests. You will continue to receive treatment as part of the study until your tests show that it has stopped working. If during the study you change your mind, you are free to leave at any point.

Eligibility

The trial will investigate the safety and efficacy of savolitinib plus osimertinib compared with the current standard of care, platinum-based doublet chemotherapy.

You may be eligible for this trial if you have NSCLC that:

• Is locally advanced or metastatic
• Has tested positive for EGFR and MET
• Has not responded to or stopped responding to treatment with osimertinib alone

For further information on eligibility, please contact a local study center. A biopsy will be required during screening to collect a small tumor tissue sample to test if your cancer is MET positive.

About Clinical Studies

WHAT IS A CLINICAL STUDY?

Clinical studies are performed to find new and improved ways of preventing, diagnosing, or treating diseases. Before they are allowed to take place, clinical studies must demonstrate that they will follow strict scientific standards. These standards protect patients and allow doctors to be confident in the study results.

To investigate a new treatment, participants are often randomly divided between two groups:

• Study treatment group, who will receive the treatment or treatments being investigated
• Control group, who will receive the current approved standard of care treatment

This approach allows researchers to compare outcomes between the two groups and determine how effective the study treatment is.