ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

Prior treatment

• Receipt of any other investigational agent within 4 weeks prior to the first dose of study treatment.
• Unresolved toxicity of CTCAE Grade ≥2 severity attributed to prior anti-tumor therapy at the time of first dose of study drug.
• Prior or concurrent malignancy other than study disease.

Other illness

• Presence of leptomeningeal disease, brainstem metastases, or spinal cord compression.
• Inability to swallow oral medication, or any gastrointestinal disease or condition that may significantly impair the absorption of the study drug.
• 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.

Lab values

• 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.

Other

• Known coexistence of other oncogenic driver gene alterations.
• Patients with symptomatic brain metastases or unstable brain metastases.

• Capable of giving signed informed consent.
• Male or female, at least 18 years of age at the time of ICF signing.
• Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, not amenable to curative surgery or radiotherapy.
• 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.
• The tumor harbors EGFR sensitizing mutation (Ex19Del or L858R).
• MET protein overexpression as determined by central laboratory testing of tumor tissue samples.
• At least one measurable lesion as assessed by RECIST v1.1.
• Have adequate organ functions.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Have an estimated life expectancy ≥ 12 weeks.