Recruiting

Phase 3

PF-08046054 vs. DocetaxelA 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

Code:

NCT07144280

Conditions

Non-small Cell Carcinoma

Non-Small Cell Lung Cancer Metastatic

Non-Small Cell Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08046054

Docetaxel monotherapy

Study Details

Brief 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.

Conditions

Non-small Cell Carcinoma

Non-Small Cell Lung Cancer Metastatic

Non-Small Cell Lung Carcinoma

Study ID

NCT07144280

Start date

Sep 29, 2025

Status verified date

Sep, 2026

Completion date

Mar 10, 2032

Anticipated

Primary completion date

Mar 10, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

680 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PF-08046054 monotherapy

PF-08046054 monotherapy

active comparator: Docetaxel monotherapy

Docetaxel monotherapy

Interventions

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.

Primary outcome measure

Overall Survival [ Time Frame: Approximately 5 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Alabama Oncology, Shelby

Recruiting

Alabaster, Alabama, United States, 35007

Alabama Oncology, Bessemer

Recruiting

Bessemer, Alabama, United States, 35022

Alabama Oncology, St Vincent's Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Alabama Oncology, Brookwood

Recruiting

Birmingham, Alabama, United States, 35209

Alabama Oncology, Princeton

Recruiting

Birmingham, Alabama, United States, 35211

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Alabama Oncology, St Vincent's East

Recruiting

Birmingham, Alabama, United States, 35235

Alabama Oncology, Grandview Cancer Center

Recruiting

Birmingham, Alabama, United States, 35243

University of Alabama at Birmingham, IDS Pharmacy

Recruiting

Birmingham, Alabama, United States, 35249

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Southern Cancer Center

Recruiting

Daphne, Alabama, United States, 36526

Southern Cancer Center, PC

Recruiting

Foley, Alabama, United States, 36535

Alaska Oncology and Hematology

Recruiting

Anchorage, Alaska, United States, 99508

Highlands Oncology Group, PA

Recruiting

Fayetteville, Arkansas, United States, 72703

Highlands Oncology Group, PA

Recruiting

Rogers, Arkansas, United States, 72758

Highlands Oncology Group, PA

Recruiting

Springdale, Arkansas, United States, 72762

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Alta Bates Summit Medical Center Comprehensive Cancer Center

Recruiting

Berkeley, California, United States, 94704

UC San Diego Medical Center - Encinitas

Recruiting

Encinitas, California, United States, 92024

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Providence St. Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

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

Recruiting

La Jolla, California, United States, 92037

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

UCSD Koman Family Outpatient Pavilion

Recruiting

La Jolla, California, United States, 92037

Roseville Medical Plaza Care Center

Recruiting

Roseville, California, United States, 95661

Sutter Medical Center, Sacramento Infusion Center at Roseville

Recruiting

Roseville, California, United States, 95661

Buhler Specialty Pavilion

Recruiting

Sacramento, California, United States, 95816

Sutter Medical Center, Sacramento Infusion Center

Recruiting

Sacramento, California, United States, 95816

UC San Diego McGrath Outpatient Pavilion - Hillcrest

Recruiting

San Diego, California, United States, 92103

UC San Diego Medical Center - Hillcrest

Recruiting

San Diego, California, United States, 92103

UCSD Medical Center - Rancho Bernardo

Recruiting

San Diego, California, United States, 92127

UC San Diego Medical Center - Vista

Recruiting

Vista, California, United States, 92081