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)

Conditions

• Non-Small Cell Lung Cancer Metastatic
• Non-Small Cell Lung Carcinoma
• Non-small Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-08046054 — DRUG
  Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.
• Docetaxel monotherapy — DRUG
  Participants will receive Docetaxel, administered as an IV infusion.

Study Details

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.

Key Dates

Start date

Sep 29, 2025

Status verified

Apr 2026

Primary completion

Mar 10, 2028

Completion

Mar 10, 2032

Study Design

Enrollment

680 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PF-08046054 monotherapy
  PF-08046054 monotherapy
• Active Comparator: Docetaxel monotherapy
  Docetaxel monotherapy

Primary Outcome Measure

Overall Survival [ Time Frame: Approximately 5 years ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (133)

Find similar trials in Alabaster, AL

Related Studies

• The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
  PHASE1/PHASE2 · Recruiting · PMV Pharmaceuticals, Inc · Irvine, California
• A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
  PHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · Miami, Florida
• Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)
  PHASE1/PHASE2 · Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer
  PHASE2 · Recruiting · University of California, Davis · Sacramento, California