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Clinical Trials in the UK / NCT05261399
Active, not recruiting Phase 3

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

NCT05261399 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-08-03
Last updated
2026-08-06

Condition(s) studied

CarcinomaNon-Small-Cell Lung

Investigational drug(s) / intervention(s)

SavolitinibOsimertinibPemetrexedCisplatinCarboplatin

Savolitinib: 300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral

Osimertinib: 80 mg osimertinib (1 × 80 mg tablet once daily) Administrative route : oral

Pemetrexed: Pemetrexed (500 mg/m2) Administrative route : IV infusion

Cisplatin: Cisplatin (75 mg/m2) Administrative route : IV infusion

Carboplatin: Carboplatin (AUC5) Administrative route : IV infusion

Study summary

Clinical study to investigate the efficacy and safety 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 NSCLC who have progressed on treatment with Osimertinib.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses. * Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted. * Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy. * Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M. * Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy. * Mandatory provision of FFPE tumour tissue. * MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment. * Measurable disease as defined by RECIST 1.1. * Adequate haematological, liver, renal and cardiac functions, and coagulation parameters. * ECOG performance status of 0 or 1. Exclusion Criteria: * Predominant squamous NSCLC, and small cell lung cancer. * Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib. * Prior or current treatment with savolitinib or another MET inhibitors. * Spinal cord compression or brain metastases, unless asymptomatic and are stable. * History or active leptomeningeal carcinomatosis. * Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL. * Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals. * History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement. * Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease. * Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention. * Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD. * Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.

Primary outcome measure(s)

Trial sites (214)

FacilityCityRegionStatus
Research Site Orlando Florida
Research Site Honolulu Hawaii
Research Site New Brunswick New Jersey
Research Site New York New York
Research Site Nashville Tennessee
Research Site Buenos Aires Argentina
Research Site CABA Argentina
Research Site Florida Argentina
Research Site La Rioja Argentina
Research Site Rosario Argentina
Research Site Rosario Argentina
Research Site San Miguel de Tucumán Argentina
Research Site Viedma Argentina
Research Site Fremantle Australia
Research Site Southport Australia
Research Site Waratah NSW Australia
Research Site Westmead Australia
Research Site Brussels Belgium
Research Site Ghent Belgium
Research Site Roeselare Belgium
Research Site Belo Horizonte Brazil
Research Site Cachoeiro de Itapemirim Brazil
Research Site Ijuí Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Salvador Brazil
Research Site Salvador Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Vitória Brazil
Research Site Toronto Ontario
Research Site Toronto Ontario
Research Site Montreal Quebec
Research Site Montreal Quebec
Research Site Santiago Chile
Research Site Baoding China
Research Site Beijing China
Research Site Beijing China
Research Site Bengbu China

+ 174 more sites — see the full list on the official registry below.

On this site

📄 Tagrisso (osimertinib) drug profile →

More AstraZeneca trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05261399 on ClinicalTrials.gov ↗ ← All trials in the UK