Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer

Inclusion criteria

• Males or females aged ≥18 to ≤75 years at the time of signing the ICF
• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
• Received one prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the locally advanced, or metastatic setting, either as monotherapy or in combination with other agents; Received one prior platinum based chemotherapy in the locally advanced, or metastatic setting, either prior to TKI, in combination with TKI, or after TKI therapy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
• Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
• Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis.

Exclusion criteria

• Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
• Other malignancies within 5 years prior to the first dose;
• History of (noninfectious) interstitial lung disease (ILD) and current ILD
• Prior HER3-targeted therapy; Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
• Pregnant or lactating women;