A Phase 3 interventional study of PF-08046054 and Docetaxel monotherapy in Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic and Non-Small Cell Lung Carcinoma, sponsored by Pfizer. Recruiting at 449 sites in 29 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
Able to provide any of the following tumor tissues for biomarker analysis:
Participants with no known AGAs must fulfill 1 of the following conditions:
Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:
Exclusion Criteria
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:
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.
PF-08046054 monotherapy
Drug: PF-08046054
Docetaxel monotherapy
Drug: Docetaxel monotherapy
Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.
Also known as: SGN-PDL1V
Participants will receive Docetaxel, administered as an IV infusion.
Overall Survival
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Approximately 5 years
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Approximately 5 years
Objective Response Rate as assessed by BICR
The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1.
Time frame: Approximately 5 years
Progression Free Survival as assessed by Investigator
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Approximately 5 years
Objective Response Rate (ORR) as assessed by Investigator
The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1.
Time frame: Approximately 5 years
Duration of Response as assessed by BICR
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Approximately 5 years
Duration of Response as assessed by Investigator
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Approximately 5 years
Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Through 90 days after the last study intervention; Approximately 5 years
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.
Time frame: Approximately 5 years
Mean scores and Change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.
Time frame: Approximately 5 years
Mean scores and Change from Baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 QLQ-LC13
The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 item questionnaire assessing lung cancer-associated symptoms and treatment-related effects.
Time frame: Approximately 5 years
Time to definitive deterioration (TTdD) in in the global health status/QoL score on the EORTC QLQ-C30
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Time frame: Approximately 5 years
TTdD in physical functioning and role functioning scores on the EORTC QLQ-C30
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Time frame: Approximately 5 years
TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Time frame: Approximately 5 years
Pharmacokinetics (PK): Plasma concentration of PF-08046054 and and its components
To characterize the pharmacokinetics (PK) of PF-08046054
Time frame: Approximately 48 weeks
Incidence of Anti-Drug Antibody (ADA)
To characterize the immunogenicity of PF-08046054
Time frame: Approximately 48 weeks
Showing the first 100 of 449 sites across 29 countries.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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