A randomized, phase 3, open-label study to evaluate SGN-B6A compared with docetaxel in adult subjects with previously treated non-small cell lung cancer

Arm A: SGN-B6A monotherapy
Arm B: standard-of-care treatment of docetaxel monotherapy

• Subjects must have NSCLC with nonsquamous histology
• An ECOG performance status score of 0 or 1.
• Subjects must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy:
• subjects with no known AGAs must fulfill 1 of the following conditions:
• Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease and a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
• Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting for early or locally advanced stage disease and received an anti-PD-(L)1 monoclonal antibody at any time during the course of treatment.
• Subjects with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:
• Must have received at least 1 relevant AGA targeted therapy and in the opinion of the investigator, additional AGA targeted therapy is not in the best interest of the subject.
• Must have received prior treatment with only 1 platinum-based chemotherapy regimen. This includes subjects who have experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the neoadjuvant and/or adjuvant setting for early or locally advanced-stage disease,
• May have received up to 1 anti-PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).

• Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to Cycle 1 Day 1.
• Evidence of noninfectious ILD or pneumonitis
• Uncontrolled diabetes mellitus, defined as HbA1c ≥8.0% or HbA1c between 7% and <8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
• Ongoing immune-mediated AEs related to prior treatment with PD-L(1) inhibitors