EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer
Conditions
Brief summary
Overall Response Rate (ORR) by investigator assessment in accordance with RECIST 1.1
Detailed description
ORR, DoR and PFS by investigator assessment in accordance with RECIST 1.1., OS, ORR, DoR, and PFS assessed by BICR 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
DRUGTAGRISSO 80 mg film-coated tablets
DRUGSavolitinib
DRUGTAGRISSO 40 mg film-coated tablets
Sponsors
AstraZeneca AB
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, DoR and PFS by investigator assessment in accordance with RECIST 1.1., OS, ORR, DoR, and PFS assessed by BICR 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. | — |
Countries
Italy, Spain
Outcome results
None listed