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RECRUITING

NCT07144280

PHASE3

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)

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

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.

Official title: PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

680

Start Date

2025-09-29

Completion Date

2032-03-10

Last Updated

2026-10-13

Healthy Volunteers

Conditions

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

Interventions

DRUG

PF-08046054

Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.

DRUG

Docetaxel monotherapy

Participants will receive Docetaxel, administered as an IV infusion.

Inclusion Criteria * Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible. * PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263. * Participants who have NSCLC with known AGAs are permitted. * Able to provide any of the following tumor tissues for biomarker analysis: * Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or * De novo biopsy from a tumor lesion, if medically feasible. * Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy: Participants 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 unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy). * Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment. Participants 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 if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant * Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting. * May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy). Exclusion Criteria * History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \[OS\] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. * Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and/or radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria: * The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least \>14 days prior to randomization (if requiring steroid treatment). * No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and/or surgery. * Time since CNS-directed treatment is ≥28 days prior to randomization. * Participants with a history of leptomeningeal metastasis are excluded. * Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives. * Previous receipt of an MMAE-containing agent or prior docetaxel. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.

Locations (447)

Alabama Oncology, Shelby

Alabaster, Alabama, United States

Alabama Oncology, Bessemer

Bessemer, Alabama, United States

Alabama Oncology, St Vincent's Birmingham

Birmingham, Alabama, United States

Alabama Oncology, Brookwood

Birmingham, Alabama, United States

Alabama Oncology, Princeton

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Alabama Oncology, St Vincent's East

Birmingham, Alabama, United States

Alabama Oncology, Grandview Cancer Center

Birmingham, Alabama, United States

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Southern Cancer Center

Daphne, Alabama, United States

Southern Cancer Center, PC

Foley, Alabama, United States

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Highlands Oncology Group, PA

Fayetteville, Arkansas, United States

Highlands Oncology Group, PA

Rogers, Arkansas, United States

Highlands Oncology Group, PA

Springdale, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Alta Bates Summit Medical Center Comprehensive Cancer Center

Berkeley, California, United States

John Muir Health Clinical Research Center

Concord, California, United States

UC San Diego Medical Center - Encinitas

Encinitas, California, United States

Providence Medical Foundation

Fullerton, California, United States

Providence St. Jude Medical Center

Fullerton, California, United States

UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Pavilion

La Jolla, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

UCSD Koman Family Outpatient Pavilion

La Jolla, California, United States

Roseville Medical Plaza Care Center

Roseville, California, United States

Sutter Medical Center, Sacramento Infusion Center at Roseville

Roseville, California, United States

Buhler Specialty Pavilion

Sacramento, California, United States

Sutter Medical Center, Sacramento Infusion Center

Sacramento, California, United States

UC San Diego McGrath Outpatient Pavilion - Hillcrest

San Diego, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

UCSD Medical Center - Rancho Bernardo

San Diego, California, United States

UC San Diego Medical Center - Vista

Vista, California, United States

John Muir Health Cancer Center

Walnut Creek, California, United States

John Muir Health Clinical Research Center

Walnut Creek, California, United States

John Muir Medical Center - Walnut Creek Campus

Walnut Creek, California, United States