Last updated on August 2019

Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib


Brief description of study

This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib.

Detailed Study Description

The combination of osimertinib with savolitinib in this study (the SAVANNAH study) will explore if the combination will overcome MET-amplification as a mechanism of resistance. The SAVANNAH study will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib.

Eligible patients will be those with histologically or cytologically confirmed diagnosis of EGFRm NSCLC that is locally advanced or metastatic and is not amenable to further surgery or radiotherapy with curative intent. The disease must have progressed following treatment with osimertinib. Patients must have confirmation of MET+ tumour by central FISH, central IHC or certain local NGS testing (requirements summarised in the main body of the protocol and fully explained in the Central Laboratory Manual). In patients centrally confirmed as MET+, MET+ is defined as a) high expression of MET (by IHC) and/or b) increased MET gene copy number (by FISH). Patients must not have received prior or current treatment with savolitinib or another MET inhibitor.

All patients confirmed as eligible will begin treatment on Day 1 with osimertinib+savolitinib. Treatment will continue od in 28 day cycles until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.

Clinical Study Identifier: NCT03778229

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