A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

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  1. Study sites: 449 to 447
  2. Trial sites expanded: 431 → 449 locations
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 2 of 15 entries
  3. Trial sites expanded: 425 → 431 locationsv10
  4. Trial sites expanded: 402 → 425 locationsv9
  5. Trial sites expanded: 305 → 402 locationsv8
  6. Trial sites expanded: 280 → 305 locationsv7
  7. Trial sites expanded: 253 → 280 locationsv6
  8. Study sites: 218 to 253v5
  9. Primary endpoints: 2 to 1
    • Study sites: 89 to 218
    • Eligibility criteria shortened, about 44 words
    • Secondary endpoints: 14 to 15
    v4
  10. Study sites: 6 to 89v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Aug 22, 2025 to Sep 29, 2025
    • Eligibility criteria expanded, about 10 words
    v2
  12. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation. Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.
Trial Details
NCT Number NCT07144280
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Carcinoma
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 680 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov