A Phase II, Single Arm Study Assessing the Efficacy of Osimertinib in Combination with Savolitinib in Patients with EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer who have Progressed Following Treatment with Osimertinib 2024-512581-34-00

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512581-34-00

Acronym

SAVANNAH

Enrollment

Registered

2024-07-24

Start date

2019-10-23

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

Brief summary

Overall Response Rate (ORR) by investigator assessment in accordance with RECIST 1.1.

Detailed description

ORR by investigator assessment in accordance with RECIST 1.1., PFS by investigator assessment in accordance with RECIST 1.1. OS DoR Percentage change in tumour size by investigator assessment in accordance with RECIST 1.1., Mean change from baseline in EORTC QLQ-C30 and QLQ-LC13., Plasma concentrations of osimertinib, savolitinib and their metabolites., Total clearance in EGFR mutations at 6-weeks after therapy initiation (percentage and absolute change from baseline in EGFR mutation allele frequencies)., AEs, SAEs and discontinuation rate due to AEs. Clinical chemistry/haematology including LFTs. ECHOs, ECGs and vital signs including blood pressure and heart rate.

Interventions

DRUGSavolitinib

DRUGTAGRISSO 80 mg film-coated tablets

DRUGTAGRISSO 40 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Response Rate (ORR) by investigator assessment in accordance with RECIST 1.1.	—

Secondary

Measure	Time frame
ORR by investigator assessment in accordance with RECIST 1.1., PFS by investigator assessment in accordance with RECIST 1.1. OS DoR Percentage change in tumour size by investigator assessment in accordance with RECIST 1.1., Mean change from baseline in EORTC QLQ-C30 and QLQ-LC13., Plasma concentrations of osimertinib, savolitinib and their metabolites., Total clearance in EGFR mutations at 6-weeks after therapy initiation (percentage and absolute change from baseline in EGFR mutation allele frequencies)., AEs, SAEs and discontinuation rate due to AEs. Clinical chemistry/haematology including LFTs. ECHOs, ECGs and vital signs including blood pressure and heart rate.	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026