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
Intervention
Arm A: SGN-B6A monotherapy Arm B: standard-of-care treatment of docetaxel monotherapy
Key inclusion criteria
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).
Key exclusion criteria
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
