Sensitizing and T790M mutant EGFR tyrosine kinase inhibition

The key inclusion criteria are¹

• 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 sensitizing EGFR mutation: exon 19 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 tumor tissue
• MET overexpression and/or amplification in tumor specimen collected following progression on prior osimertinib treatment
• Adequate haematological, liver, renal and cardiac functions, and coagulation parameters
• ECOG performance status of 0 or 1
• At least one measurable lesion not previously irradiated (RECIST v1.1 requirements)

Reference:

1. Study NCT05261399. ClinicalTrials.gov website

The key exclusion criteria are¹

• 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 at the time of starting study intervention with the exception of alopecia and hemoglobin ≥ 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 infections 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