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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-08046054 monotherapy 		PF-08046054 monotherapy
  • Drug: PF-08046054
    Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.
    Other names:
    • SGN-PDL1V
Active Comparator
Docetaxel monotherapy 		Docetaxel monotherapy
  • Drug: Docetaxel monotherapy
    Participants will receive Docetaxel, administered as an IV infusion.

Recruiting Locations

Alabama Oncology
Alabaster, Alabama 35007

Alabama Oncology
Bessemer, Alabama 35022

Alabama Oncology, Bruno Cancer Center
Birmingham, Alabama 35205

Alabama Oncology
Birmingham, Alabama 35209

Alabama Oncology
Birmingham, Alabama 35211

Alabama Oncology
Birmingham, Alabama 35235

Alabama Oncology
Birmingham, Alabama 35243

Southern Cancer Center
Daphne, Alabama 36526

Southern Cancer Center, PC
Foley, Alabama 36535

Alaska Oncology and Hematology
Anchorage, Alaska 99508

Rocky Mountain Cancer Centers,LLP
Denver, Colorado 80218

Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida 32901

Florida Cancer Affiliates - Panama City
Panama City, Florida 32405

Illinois CancerCare- Bloomington
Bloomington, Illinois 61704

Illinois CancerCare Galesburg
Galesburg, Illinois 61401

Accellacare of Duly
Lisle, Illinois 60532

Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois 61350

Illinois CancerCare- Pekin
Pekin, Illinois 61554

Illinois Cancer Care
Peoria, Illinois 61615

Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois 61354

Illinois CancerCare - Washington
Washington, Illinois 61571

Minnesota Oncology Hematology, PA
Burnsville, Minnesota 55337

Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota 55433

Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota 55433

Minnesota Oncology Hematology, P.A.
Edina, Minnesota 55435

Minnesota Oncology Hematology PA
Maple Grove, Minnesota 55369

Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota 55109

Minnesota Oncology Hematology, P.A...
Minneapolis, Minnesota 55404

Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota 55407

Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota 55102

Minnesota Oncology Hematology, PA
Woodbury, Minnesota 55125

Missouri Cancer Associates
Columbia, Missouri 65201

Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York 10461

White Plains Hospital
White Plains, New York 10601

Oncology Hematology Care Inc
Cincinnati, Ohio 45211

Oncology Hematology Care
Cincinnati, Ohio 45242

Oncology Hematology Care Inc
Cincinnati, Ohio 45245

Oncology Hematology Care Inc
Fairfield, Ohio 45014

Oncology Associates of Oregon, P.C.
Eugene, Oregon 97401

Alliance Cancer Specialists, PC
Bensalem, Pennsylvania 19020

Consultants in Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania 19008

Alliance Cancer Specialists, PC
Doylestown, Pennsylvania 18901

Alliance Cancer Specialists, PC
Horsham, Pennsylvania 19044

Alliance Cancer Specialists, P.C.
Langhorne, Pennsylvania 19047

Alliance Cancer Specialists, PC
Media, Pennsylvania 19063

Alliance Cancer Specialists, PC
Sellersville, Pennsylvania 18960

Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania 19096

Tennessee Cancer Specialists
Knoxville, Tennessee 37909

Texas Oncology - West Texas
Abilene, Texas 79606

Texas Oncology-Northeast Texas
Allen, Texas 75013

Texas Oncology- Central South.
Austin, Texas 78705

Texas Oncology Central South
Austin, Texas 78731

Texas Oncology- Central South.
Austin, Texas 78745

Texas Oncology - Central South (Renfert Way)
Austin, Texas 78758

Texas Oncology - Gulf Coast
Beaumont, Texas 77702

The University of Texas, MD Anderson Cancer Center - Woodlands
Conroe, Texas 77384

Texas Oncology - Dallas (Sammons)
Dallas, Texas 75246

Texas Oncology-Northeast Texas
Denison, Texas 75020

Texas Oncology-Northeast Texas
Denton, Texas 76201

Texas Oncology-Northeast Texas
Flower Mound, Texas 75028

Texas Oncology- Central South
Harlingen, Texas 78550

The University of Texas MD Anderson Cancer Center Diagnostic Imaging
Houston, Texas 77030

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030

The University of Texas, MD Anderson Cancer Center- Interventional Radiology
Houston, Texas 77030

University of Texas MD Anderson Cancer Center
Houston, Texas 77030

The University of Texas MD Anderson Cancer Center Clinical Research Imaging
Houston, Texas 77054

The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas 77079

US Oncology Investigational Product Center (IPC)
Irving, Texas 75063

US Oncology Investigational Products Center (IPC)
Irving, Texas 75063

US Oncology Investigational Products Center(IPC)
Irving, Texas 75063

The University of Texas, MD Anderson Cancer Center - League City
League City, Texas 77573

Texas Oncology-Northeast Texas
Lewisville, Texas 75056

Texas Oncology-Northeast Texas
Longview, Texas 75601

Texas Oncology
McAllen, Texas 78503

Texas Oncology-Northeast Texas
McKinney, Texas 75071

Texas Oncology-Northeast Texas
Palestine, Texas 75801

Texas Oncology-Northeast Texas
Paris, Texas 75460

Texas Oncology - Gulf Coast
Pearland, Texas 77584

The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas 77478

Texas Oncology - Gulf Coast
Sugar Land, Texas 77479

Texas Oncology - Gulf Coast
The Woodlands, Texas 77380

Texas Oncology-Northeast Texas
Tyler, Texas 75702

Texas Oncology- Central South
Waco, Texas 76712

Texas Oncology-Central South
Waco, Texas 76712

Texas Oncology - Central South
Weslaco, Texas 78596

American Oncology Network Vista Oncology Division-West office
Olympia, Washington 98502

American Oncology Network Vista Oncology Division-East office
Olympia, Washington 98506

Ad-Vance Medical Research
Ponce, Puerto Rico 00717

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.