AndroMETa-Lung-713: Targeted treatment compared to standard of care for people with advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutationPhase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI

Inclusion

• 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.
• Provide archived or recently obtained tumor tissue during Screening.
• Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry.
• 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 that required steroids should be excluded.
• If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.