A Study of PF-08046054 Versus Docetaxel for Previously-Treated Lung Cancer
This study is looking at whether a medicine called PF-08046054 works better than standard docetaxel for adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Your cancer must have a specific marker called PD-L1 (Programmed Cell Death Ligand 1) and have progressed after previous treatments. This includes if your cancer has spread or cannot be removed by surgery or treated with radiation. The study aims to see how long people live (Overall Survival) when taking PF-08046054 compared to docetaxel. You would be randomly assigned to receive either PF-08046054 or docetaxel, both given through an IV.
- Study design
- This study plans to enroll 680 participants. You would be randomly assigned to one of two treatment groups, like flipping a coin.
- What's involved
- Participants will receive either PF-08046054 or Docetaxel, administered as an IV infusion. Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure Overall Survival at approximately 5 years, indicating a long-term follow-up period.
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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)
Recruiting
PHASE3Ages 18+InterventionalTreatmentPfizer
~680 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08046054Docetaxel monotherapy
At a glance
Recruiting sites
359 of 425 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over Approximately 5 years
Conditions
Where it's being run
425 sites across 149 statesTexas53
Tennessee22
California15
Colorado14
Oregon13
Alabama12
Illinois10
Minnesota10
Study leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
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.
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
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.
What this trial measures
- Overall SurvivalApproximately 5 years
Overall survival defined as the time from the date of randomization to the date of death due to any cause.