A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation

Required: EGFR activating mutation

Patients with confirmed EGFR activating mutations that are sensitive to EGFR TKI at any time after initial diagnosis

Required: EGFR G719X

dose escalation part including G719X, exon 19 deletion, L858R, L861Q

Required: EGFR exon 19 deletion

dose escalation part including G719X, exon 19 deletion, L858R, L861Q; dose expansion part including exon 19 deletion and L858R

Required: EGFR L858R

dose escalation part including G719X, exon 19 deletion, L858R, L861Q; dose expansion part including exon 19 deletion and L858R

Required: EGFR L861Q

dose escalation part including G719X, exon 19 deletion, L858R, L861Q

Excluded: EGFR exon 20 insertion

confirmed EGFR 20 exon insertion mutations

Must have received: EGFR tyrosine kinase inhibitor (gefitinib, erlotinib, icotinib, afatinib) — locally advanced or metastatic

disease progression (with imaging evidence) while on previous continuous treatments with EGFR-TKI (such as gefitinib, erlotinib, icotinib, afatinib, etc., excluding the third-generation EGFR TKI drugs), or cannot tolerate the treatments for various reasons (only applicable to dose escalation part)

Cannot have received: third-generation EGFR TKI (osimertinib, rociletinib, olmutinib, asp8273, egf816, mefatinib, avitinib)

Patients who have used the third generation EGFR TKI drugs (such as Osimertinib, rociletinib (co-1686), olmutinib (hm61713), asp8273, egf816, Mefatinib, Avitinib, etc.)

Cannot have received: chemotherapy

Exception: chemotherapy within 28 days before first administration

Within 28 days before the first administration of the study treatment, the patients have used any chemotherapy drugs and / or immunotherapy drugs in the previous treatment regimen or clinical study

Cannot have received: immunotherapy

Exception: immunotherapy within 28 days before first administration

Within 28 days before the first administration of the study treatment, the patients have used any chemotherapy drugs and / or immunotherapy drugs in the previous treatment regimen or clinical study

Cannot have received: experimental drug

Exception: experimental drug or other anticancer drugs within 14 days before first administration, or stopped using other experimental drugs or anticancer drugs for less than 5 ×half-life

the patient have used an experimental drug or other anticancer drugs in the previous treatment regimen or clinical study within 14 days before the first administration of the study treatment, or stopped using other experimental drugs or anticancer drugs for less than 5 ×half-life