OncoMatch/Clinical Trials/NCT07144280
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)
Is NCT07144280 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including PF-08046054 and Docetaxel monotherapy for non-small cell carcinoma.
Treatment: PF-08046054 · Docetaxel monotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression ≥1% of tumor cells (≥1% of tumor cells)
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
Allowed: EGFR sensitizing mutation
Participants who have NSCLC with known AGAs are permitted. ... known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations)
Allowed: ALK fusion
Participants who have NSCLC with known AGAs are permitted. ... known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations)
Disease stage
Required: Stage IIIB, IIIC, IV: M1A, IV: M1B, IV: M1C
Prior therapy
Must have received: platinum-based chemotherapy — metastatic or recurrent disease
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease
Must have received: anti-PD-1/PD-L1 therapy — metastatic or recurrent disease
unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy)
Cannot have received: anti-PD-L1 therapy
Exception: within 5 half-lives
Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives
Cannot have received: antibody-drug conjugate (MMAE-containing agent)
Previous receipt of an MMAE-containing agent
Cannot have received: taxane (docetaxel)
prior docetaxel
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Alabama Oncology · Alabaster, Alabama
- Alabama Oncology · Bessemer, Alabama
- Alabama Oncology, Bruno Cancer Center · Birmingham, Alabama
- Alabama Oncology · Birmingham, Alabama
- Alabama Oncology · Birmingham, Alabama
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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