Clinical Research Directory

Inclusion Criteria: 1. Capable of giving signed informed consent. 2. Male or female, at least 18 years of age at the time of ICF signing. 3. Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, not amenable to curative surgery or radiotherapy. 4. Patients must have untreated advanced NSCLC not amenable to curative surgery or radiotherapy. Prior adjuvant and neo-adjuvant therapies or definitive radiation/chemoradiation are permitted as long as treatment was completed at least 6 months prior to the development of recurrent disease. 5. The tumor harbors EGFR sensitizing mutation (Ex19Del or L858R). 6. MET protein overexpression as determined by central laboratory testing of tumor tissue samples. 7. At least one measurable lesion as assessed by RECIST v1.1. 8. Have adequate organ functions. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 10. Have an estimated life expectancy ≥ 12 weeks. Exclusion Criteria: 1. Known coexistence of other oncogenic driver gene alterations. 2. Prior therapy with an EGFR inhibitor (Patients who have completed the maximum permitted duration of adjuvant therapy and whose disease progressed or recurred ≥12 months after completion of such therapy are eligible for enrollment) or a c-MET-targeted inhibitor. 3. Receipt of any other investigational agent within 4 weeks prior to the first dose of study treatment. 4. Unresolved toxicity of CTCAE Grade ≥2 severity attributed to prior anti-tumor therapy at the time of first dose of study drug. 5. Patients with symptomatic brain metastases or unstable brain metastases. 6. Presence of leptomeningeal disease, brainstem metastases, or spinal cord compression. 7. Prior or concurrent malignancy other than study disease. 8. Inability to swallow oral medication, or any gastrointestinal disease or condition that may significantly impair the absorption of the study drug. 9. Any other serious or uncontrolled acute or chronic medical condition that, in the investigator's judgment, would render the patient unsuitable for participation in the study.