• Patients must meet all the following criteria for inclusion in the study:

• Sufficient understanding of nature of the trial and provision of informed consent with hand-written signatures and the date of signature prior to any study-specific procedures, sampling, and analyses.

• Age ≥ 18 years.

• Histologically or cytologically confirmed and locally advanced or metastatic non-squamous NSCLC.

• Written documentation of EGFR mutations from an accredited local laboratory: Part A is not limited to a specific EGFR mutation, and Part B only includes patients with EGFR Exon20ins.

• ECOG score ≤ 1 without clinically significant disease deterioration within 2 weeks prior to the informed consent process and a life expectancy ≥ 12 weeks.

• Patients with stable brain metastasis provided no evidence of progression for at least 2 weeks, as ascertained by brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan) during the screening period, no neurological symptoms, and no requirement of Steroids.

• Part A includes patients who have progressed after or cannot tolerate the standard of care

• Part B includes patients with NSCLC who have progressed after or cannot tolerate standard of care. Treatment naïve patients will be enrolled after an adequate evaluation of the safety data by the Safety Review Committee (Note: Patients who have received (neo)adjuvant therapy are allowed to participate in the study, if the (neo)adjuvant therapy is administrated at least 6 months prior to the diagnosis of locally advanced or metastatic NSCLC) .

• Measurable lesions, according to RECIST 1.1: at least one lesion, not previous irradiated, with the longest diameter ≥ 10 mm at baseline (lymph nodes must have a short axis of ≥ 15 mm), that can be accurately measured at baseline and thereafter with MRI or CT scan.

⁃ Male patients with a female partner or fertility desire should be willing to use barrier contraception (e.g., condoms) until 6 months after the last dose. Male patients should not donate sperms until 6 months after the last dose. Male patients with fertility desire are suggested to freeze their sperm before entering the study.

⁃ Female patients should be willing to use adequate contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test (i.e., urine and blood pregnancy human chorionic gonadotropin testing); or female patients meet the following criteria:

∙ Post-menopausal defined as age more than 60 and amenorrheic for at least 12 months after all exogenous hormonal treatments.

‣ Women under 60 years old would be considered post-menopausal if they have been amenorrheic for at least 12 months with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range.

‣ Documentation of irreversible surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation).