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)
Non-small Cell CarcinomaNon-Small Cell Lung Cancer MetastaticNon-Small Cell Lung Carcinoma
Investigational drug(s) / intervention(s)
PF-08046054Docetaxel monotherapy
PF-08046054: Antibody Drug Conjugate
Participants will receive PF-08046054, administered as an IV infusion.
Docetaxel monotherapy: Participants will receive Docetaxel, administered as an IV infusion.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall Survival — Approximately 5 years Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Trial sites (431)
Facility
City
Region
Status
Alabama Oncology, Shelby
Alabaster
Alabama
Recruiting
Alabama Oncology, Bessemer
Bessemer
Alabama
Recruiting
Alabama Oncology, St Vincent's Birmingham
Birmingham
Alabama
Recruiting
Alabama Oncology, Brookwood
Birmingham
Alabama
Recruiting
Alabama Oncology, Princeton
Birmingham
Alabama
Recruiting
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
Alabama Oncology, St Vincent's East
Birmingham
Alabama
Recruiting
Alabama Oncology, Grandview Cancer Center
Birmingham
Alabama
Recruiting
University of Alabama at Birmingham, IDS Pharmacy
Birmingham
Alabama
Recruiting
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
Southern Cancer Center
Daphne
Alabama
Recruiting
Southern Cancer Center, PC
Foley
Alabama
Recruiting
Alaska Oncology and Hematology
Anchorage
Alaska
Recruiting
Highlands Oncology Group, PA
Fayetteville
Arkansas
Recruiting
Highlands Oncology Group, PA
Rogers
Arkansas
Recruiting
Highlands Oncology Group, PA
Springdale
Arkansas
Recruiting
Highlands Oncology Group
Springdale
Arkansas
Recruiting
Alta Bates Summit Medical Center Comprehensive Cancer Center
Berkeley
California
Recruiting
John Muir Health Clinical Research Center
Concord
California
Not Yet Recruiting
UC San Diego Medical Center - Encinitas
Encinitas
California
Recruiting
Providence Medical Foundation
Fullerton
California
Recruiting
Providence St. Jude Medical Center
Fullerton
California
Recruiting
UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Pavilion
La Jolla
California
Recruiting
UC San Diego Moores Cancer Center
La Jolla
California
Recruiting
UCSD Koman Family Outpatient Pavilion
La Jolla
California
Recruiting
Roseville Medical Plaza Care Center
Roseville
California
Recruiting
Sutter Medical Center, Sacramento Infusion Center at Roseville
Roseville
California
Recruiting
Buhler Specialty Pavilion
Sacramento
California
Recruiting
Sutter Medical Center, Sacramento Infusion Center
Sacramento
California
Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego
California
Recruiting
UC San Diego Medical Center - Hillcrest
San Diego
California
Recruiting
UCSD Medical Center - Rancho Bernardo
San Diego
California
Recruiting
UC San Diego Medical Center - Vista
Vista
California
Recruiting
John Muir Health Cancer Center
Walnut Creek
California
Not Yet Recruiting
John Muir Health Clinical Research Center
Walnut Creek
California
Not Yet Recruiting
John Muir Medical Center - Walnut Creek Campus
Walnut Creek
California
Not Yet Recruiting
Rocky Mountain Cancer Centers LLP
Aurora
Colorado
Recruiting
Rocky Mountain Cancer Centers LLP
Boulder
Colorado
Recruiting
Rocky Mountain Cancer Centers LLP
Centennial
Colorado
Recruiting
Rocky Mountain Cancer Centers LLP
Colorado Springs
Colorado
Recruiting
+ 391 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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