Clinical Trial

A randomized, Phase 3, open-label study to evaluate PF-08046054/SGN-PDL1V vs Docetaxel in adult participants with previously-treated programmed cell death ligand (PD-L1) positive non-small cell lung cancer (NSCLC)

MOA: F-08046054/SGN-PDL1V is an anti-PD-L1 ADC with a MMAE payload

Key Eligibility Criteria:

• Histologically or cytologically documented unresectable Stage IIIB, IIIC, IV NSCLC not eligible for definitive chemoradiotherapy.
  • Tumors with small cell and neuroendocrine histology components are excluded
• PD-L1 expression on ≥1% of tumor cells based on local IHC testing
• Participants who have NSCLC with known AGAs are permitted
• Archival or fresh tissue required for biomarker analysis.
• Pts must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy:
  • Pts with no known AGA: must have received chemo + anti-PD-L1 mAb
  • Pts with known AGAs: must have received at least 1 approved targeted therapy, chemotherapy, and an anti-PD-L1 mAb.
• Brain metastases are excluded unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention
• Prior tx with an anti-PD-L1 agent within 5 half-lives are excluded
• Prior receipt of an MMAE-containing agent or docetaxel are excluded