TROPION-LUNG01

Key outcome parameters

Intervention

Therapeutic Drug Monitoring

Key inclusion criteria

Inclusion criteria:

• AGA positive status
• Has been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved for the subject’s genomic alteration at the time of screening; OR one or more of the agents specified in the table below:
  • Subjects who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior Osimertinib
  • Those who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease
  • Subjects who have been treated with a prior TKI must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable
    genomic alteration, or the subject will not be allowed in the study
• Has received platinum-based chemotherapy as the only prior line of cytotoxic therapy:
  • One platinum-containing regimen for advanced disease
  • Those who received a platinum-containing regimen as adjuvant therapy for earlystage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of platinumcontaining therapy (which may or may not be same as in the adjuvant setting) for relapsed/progressive disease
• May have received up to one α-PD-1/α-PD-L1 monoclonal antibody alone or in combination with a cytotoxic agent
• ECOG 0-1 performance status

Key exclusion criteria

Exclusion criteria:

• Has mixed small-cell lung cancer (SCLC) and NSCLC histology
• Has spinal cord compression or clinically active central nervous system (CNS) metastases
• Had prior treatment with:
  • Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.
  • TROP2-targeted therapy.
  • Docetaxel
• Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease
• Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening