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)
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)
- Non-small Cell Carcinoma
- Non-Small Cell Lung Cancer Metastatic
- Non-Small Cell Lung Carcinoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 680
- Started
- 29 September 2025
- Main results due
- 10 March 2028
- Study sites
- 449
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(449)
Alabama Oncology, Shelby
Alabaster, Alabama, United States
Recruiting
Alabama Oncology, Bessemer
Bessemer, Alabama, United States
Recruiting
Alabama Oncology, St Vincent's Birmingham
Birmingham, Alabama, United States
Recruiting
Alabama Oncology, Brookwood
Birmingham, Alabama, United States
Recruiting
Alabama Oncology, Princeton
Birmingham, Alabama, United States
Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Alabama Oncology, St Vincent's East
Birmingham, Alabama, United States
Recruiting
Alabama Oncology, Grandview Cancer Center
Birmingham, Alabama, United States
Recruiting
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States
Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Southern Cancer Center
Daphne, Alabama, United States
Recruiting
Southern Cancer Center, PC
Foley, Alabama, United States
Recruiting
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Recruiting
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States
Recruiting
Highlands Oncology Group, PA
Rogers, Arkansas, United States
Recruiting
Highlands Oncology Group, PA
Springdale, Arkansas, United States
Recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
Alta Bates Summit Medical Center Comprehensive Cancer Center
Berkeley, California, United States
Recruiting
John Muir Health Clinical Research Center
Concord, California, United States
Recruiting
UC San Diego Medical Center - Encinitas
Encinitas, California, United States
Recruiting
Providence Medical Foundation
Fullerton, California, United States
Recruiting
Providence St. Jude Medical Center
Fullerton, California, United States
Recruiting
UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Pavilion
La Jolla, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
UCSD Koman Family Outpatient Pavilion
La Jolla, California, United States
Recruiting
Roseville Medical Plaza Care Center
Roseville, California, United States
Recruiting
Sutter Medical Center, Sacramento Infusion Center at Roseville
Roseville, California, United States
Recruiting
Buhler Specialty Pavilion
Sacramento, California, United States
Recruiting
Sutter Medical Center, Sacramento Infusion Center
Sacramento, California, United States
Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, United States
Recruiting
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Recruiting
UCSD Medical Center - Rancho Bernardo
San Diego, California, United States
Recruiting
UC San Diego Medical Center - Vista
Vista, California, United States
Recruiting
John Muir Health Cancer Center
Walnut Creek, California, United States
Recruiting
John Muir Health Clinical Research Center
Walnut Creek, California, United States
Recruiting
John Muir Medical Center - Walnut Creek Campus
Walnut Creek, California, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Aurora, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Boulder, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Centennial, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Colorado Springs, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Colorado Springs, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers,LLP
Denver, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Denver, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Englewood, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Lakewood, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Littleton, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Lone Tree, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Longmont, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Pueblo, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers LLP
Thornton, Colorado, United States
Recruiting
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Recruiting
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Recruiting
Florida Cancer Affiliates - Panama City
Panama City, Florida, United States
Recruiting
Tennessee Oncology, PLLC - Dalton
Dalton, Georgia, United States
Recruiting
Tennessee Oncology, PLLC - Ringgold
Ringgold, Georgia, United States
Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Recruiting
Illinois CancerCare- Bloomington
Bloomington, Illinois, United States
Recruiting
Illinois Cancer Specialists
Chicago, Illinois, United States
Recruiting
Illinois CancerCare Galesburg
Galesburg, Illinois, United States
Recruiting
Accellacare of Duly
Lisle, Illinois, United States
Recruiting
Showing 60 of 449 sites — filter to narrow it down. 423 of the 449 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07144280. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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