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)
Recruiting · NCT07144280 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Docetaxel monotherapyPF-08046054
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 29 US states.
- 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
- Rocky Mountain Cancer Centers LLP - Aurora, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Boulder, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Centennial, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers,LLP - Denver, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Denver, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Englewood, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Lakewood, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Littleton, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Lone Tree, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Longmont, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Pueblo, Colorado, United States
- Rocky Mountain Cancer Centers LLP - Thornton, Colorado, United States
- Medical Oncology Hematology Consultants, PA - Newark, Delaware, United States
- Cancer Care Centers of Brevard, Inc. - Palm Bay, Florida, United States
- Florida Cancer Affiliates - Panama City - Panama City, Florida, United States
- Tennessee Oncology, PLLC - Dalton - Dalton, Georgia, United States
- Southeastern Regional Medical Center - Newnan, Georgia, United States
- Tennessee Oncology, PLLC - Ringgold - Ringgold, Georgia, United States
- Illinois Cancer Specialists - Arlington Heights, Illinois, United States
- Illinois CancerCare- Bloomington - Bloomington, Illinois, United States
- Illinois Cancer Specialists - Chicago, Illinois, United States
- Illinois CancerCare Galesburg - Galesburg, Illinois, United States
Showing 60 of 431 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →