TROPION-LUNG01

PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS DOCETAXEL IN PREVIOUSLY TREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH ACTIONABLE GENOMIC ALTERATIONS

Inclusion is only open for subjects with AGA:

A. 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.

B. 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.

C. 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

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