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

• Status: Not yet recruiting
• Trial end date: 2026-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Carboplatin; Osimertinib; Pemetrexed

Criteria

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 (≥ 20 years of age in Japan) 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:

• 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 with the exception of alopecia, haemoglobin ≥ 9.0 g/dL, and Grade 2 prior platinum-therapy related neuropathy.

• 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.