临床试验/NCT07144280

NCT07144280招募中3 期

PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate 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)

Pfizer537 个研究点分布在 8 个国家目标入组 680 人开始时间: 2025年9月29日最近更新: 2026年9月4日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: Pfizer
入组人数: 680
试验地点: 537
主要终点: Overall Survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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 SP
•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 AGAs must fulfill 1 of the following conditions:
•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.
•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 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).

排除标准

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

研究组 & 干预措施

Docetaxel monotherapy

Active Comparator

Docetaxel monotherapy

干预措施: Docetaxel monotherapy (Drug)

PF-08046054 monotherapy

Experimental

PF-08046054 monotherapy

干预措施: PF-08046054 (Drug)

结局指标

主要结局

Overall Survival

时间窗: Approximately 5 years

Overall survival defined as the time from the date of randomization to the date of death due to any cause.

Overall Survival

时间窗: Approximately 5 years

Overall survival defined as the time from the date of randomization to the date of death due to any cause.

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

时间窗: Approximately 5 years

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.

次要结局

Objective Response Rate as assessed by BICR(Approximately 5 years)
Progression Free Survival as assessed by Investigator(Approximately 5 years)
Objective Response Rate (ORR) as assessed by Investigator(Approximately 5 years)
Duration of Response as assessed by Investigator(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)(Approximately 5 years)
Mean scores and Change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30(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(Approximately 5 years)
Time to definitive deterioration (TTdD) in in the global health status/QoL score on the EORTC QLQ-C30(Approximately 5 years)
TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13(Approximately 5 years)
Incidence of Anti-Drug Antibody (ADA)(Approximately 48 weeks)
Objective Response Rate as assessed by BICR(Approximately 5 years)
Progression Free Survival as assessed by Investigator(Approximately 5 years)
Objective Response Rate (ORR) as assessed by Investigator(Approximately 5 years)
Duration of Response as assessed by BICR(Approximately 5 years)
Duration of Response as assessed by Investigator(Approximately 5 years)
Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation(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)(Approximately 5 years)
Mean scores and Change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30(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(Approximately 5 years)
Time to definitive deterioration (TTdD) in in the global health status/QoL score on the EORTC QLQ-C30(Approximately 5 years)
TTdD in physical functioning and role functioning scores on the EORTC QLQ-C30(Approximately 5 years)
TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13(Approximately 5 years)
Pharmacokinetics (PK): Plasma concentration of PF-08046054 and and its components(Approximately 48 weeks)
Incidence of Anti-Drug Antibody (ADA)(Approximately 48 weeks)
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)(Approximately 5 years)

研究者

发起方

Pfizer

申办方类型

Industry

责任方

Sponsor

研究点 (537)

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