A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

Inclusion Criteria:

1. Males or females aged ≥18 to ≤75 years at the time of signing the ICF;

2. Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable toradical surgery and/or radical concurrent/sequential chemoradiotherapy;

3. EGFR-sensitive mutations;

4. Failure of prior EGFR-TKI therapy;

5. At least one measurable target lesion per RECIST 1.1 as assessed by theinvestigator;

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

7. Expected survival ≥12 weeks;

8. Adequate organ and bone marrow function;

9. Female subjects of childbearing potential and male subjects with partners ofchildbearing potential who use effective medical contraception from the time ofsigning the informed consent form until 6 months after the last dose;

10. Subjects voluntarily participate in the study, sign the ICF, and will be able tocomply with the protocol-specified visits and relevant procedures

Exclusion Criteria:

1. Histologically or cytologically confirmed presence of small cell lung cancer,neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinomacomponents of more than 10%;

2. Other malignancies within 3 years prior to the first dose;

3. History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitisrequiring steroid therapy and current ILD/noninfectious pneumonitis;

4. Subjects with active chronic inflammatory bowel disease, GI tract obstruction,severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tractbleed;

5. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria;

6. Subjects with human immunodeficiency virus (HIV) test positive or history ofacquired immunodeficiency syndrome (AIDS); known active syphilis infection;

7. Prior TROP2-targeted therapy;

8. Prior treatment with any drug therapy targeting topoisomerase I inhibitor, includingantibody-drug conjugates (ADCs);

9. Major surgery within 4 weeks prior to the first dose or expected to require majorsurgery during the study;

10. Subjects who have received live vaccines within 30 days prior to the first dose, orare scheduled to receive live vaccines during the study;

11. Pregnant or lactating women;