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

Running, not enrolling · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID: NCT05261399
Run by: AstraZeneca
People needed: 341
Starts: 2022-08-03
Expected to finish: 2026-11-23
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Honolulu, Hawaii, United States
Research Site — New Brunswick, New Jersey, United States
Research Site — New York, New York, United States
Research Site — Nashville, Tennessee, United States
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 — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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