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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

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Category

Thoracic Cancer

PDL1V | PD-L1-directed Antibody Drug Conjugate

PF-08046054 is an investigational compound. Its safety and efficacy have not been established

A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDLlV VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-Ll) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)

Phase 3

NCT07144280

Active enrolling

Globe

Locations

United States, Australia, Canada, China, Israel, Japan, Poland, Puerto Rico, South Korea, Spain, Taiwan

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Study design
Participant Group/Arm

EXPERIMENTAL: PF-08046054 monotherapy

PF-08046054 monotherapy

Intervention/Treatment

DRUG: PF-08046054

Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.
Participant Group/Arm

ACTIVE_COMPARATOR: Docetaxel monotherapy

Docetaxel monotherapy

Intervention/Treatment

DRUG: Docetaxel monotherapy

Participants will receive Docetaxel, administered as an IV infusion.
Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
Inclusion Criteria 1. Histologically or cytologically confirmed diagnosis of locally advanced, unresectable Stage IIIB and IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) NSCLC 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. 2. 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. 3. Participants who have NSCLC with known AGAs are permitted (eg, estimated glomerular filtration rate (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations). 4. 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 * Fresh tissue from a tumor lesion, if medically feasible. 5. Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior 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 a PD-L1 or PD-1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
  • 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-L1 or PD-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 approved AGA-targeted therapy 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-1 or PD-L1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Exclusion Criteria 1. 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. 2. Active central nervous system (CNS) lesions are excluded. Active is defined as untreated or symptomatic requiring corticosteroids \>10 mg/day of prednisone equivalent within the previous 14 days. Participants with clinically inactive, definitively treated brain metastases (surgery and/or radiotherapy) 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 (if requiring steroid treatment). * No evidence of clinical and radiographic disease progression in the CNS for ≥28 days after definitive radiotherapy and/or surgery. * The use of corticosteroids at higher dose occurring ≥28 days prior to the Screening visit unless it is intermittent use for other medical conditions and allowed as a concomitant therapy. 3. Participants with a history of leptomeningeal metastasis are excluded. 4. Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives. 5. Previous receipt of an Monomethyl auristatin E (MMAE)-containing agent or prior docetaxel. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.
Exclusion criteria
  1. 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.

  2. Active central nervous system (CNS) lesions are excluded. Active is defined as untreated or symptomatic requiring corticosteroids >10 mg/day of prednisone equivalent within the previous 14 days.

    Participants with clinically inactive, definitively treated brain metastases (surgery and/or radiotherapy) 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 (if requiring steroid treatment).
    • No evidence of clinical and radiographic disease progression in the CNS for ≥28 days after definitive radiotherapy and/or surgery.
    • The use of corticosteroids at higher dose occurring ≥28 days prior to the Screening visit unless it is intermittent use for other medical conditions and allowed as a concomitant therapy.
  3. Participants with a history of leptomeningeal metastasis are excluded.
  4. Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.
  5. Previous receipt of an Monomethyl auristatin E (MMAE)-containing agent or prior docetaxel.

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.

Key dates
Study start date
  • September 2025
Estimated Study Completion Date
  • March 2032
Key endpoints
Primary Outcome Measures
Outcome Measure

Overall Survival

Measure Description

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

Outcome Measure

Progression Free Survival (PFS) assessed by blinded independent central review (BICR)

Measure Description

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

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Objective Response Rate as assessed by BICR

Measure Description

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

Outcome Measure

Progression Free Survival as assessed by Investigator

Measure Description

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

Outcome Measure

Objective Response Rate (ORR) as assessed by Investigator

Measure Description

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

Outcome Measure

Duration of Response as assessed by BICR

Measure Description

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

Outcome Measure

Duration of Response as assessed by Investigator

Measure Description

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

Outcome Measure

Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation

Measure Description

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

Outcome Measure

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)

Measure Description

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

Outcome Measure

Mean scores and Change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30

Measure Description

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

Outcome Measure

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

Measure Description

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

Outcome Measure

Time to definitive deterioration (TTdD) in in the global health status/QoL score on the EORTC QLQ-C30

Measure Description

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

Outcome Measure

TTdD in physical functioning and role functioning scores on the EORTC QLQ-C30

Measure Description

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

Outcome Measure

TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13

Measure Description

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

Outcome Measure

Pharmacokinetics (PK): Plasma concentration of PF-08046054 and and its components

Measure Description

To characterize the pharmacokinetics (PK) of PF-08046054

Time Frame

Approximately 48 weeks

Outcome Measure

Incidence of Anti-Drug Antibody (ADA)

Measure Description

To characterize the immunogenicity of PF-08046054

Time Frame

Approximately 48 weeks

Secondary Outcome Measures table for Clinical Trial
Number of participants

680

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of December 15th 2025.

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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT07144280