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Compares treatment options for Non-small Cell Carcinoma
Official title 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)
ClinicalTrials.gov ID: NCT07144280
What this study is testing
What is PF-08046054?
PF-08046054 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell carcinoma.
Also referred to as SGN-PDL1V.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive...
- PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody...
- 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
You likely can't join if
- History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed...
- Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and/or radiotherapy). Participants...
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Alabaster, Alabama, United States
- Bessemer, Alabama, United States
- Birmingham, Alabama, United States
- Daphne, Alabama, United States
- Foley, Alabama, United States
- Anchorage, Alaska, United States
- Fayetteville, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Fullerton, California, United States
- Denver, Colorado, United States
- Newark, Delaware, United States
- Palm Bay, Florida, United States
- Panama City, Florida, United States
- Dalton, Georgia, United States
- Ringgold, Georgia, United States
- Arlington Heights, Illinois, United States
- Bloomington, Illinois, United States
- Chicago, Illinois, United States
- Galesburg, Illinois, United States
+ 235 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alabaster, Alabama, United States; Bessemer, Alabama, United States; Birmingham, Alabama, United States; Daphne, Alabama, United States; Foley, Alabama, United States; Anchorage, Alaska, United States and 249 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.