Last updated 11 days ago
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)
680 patients around the world
Available in Puerto Rico, Argentina, United States, Mexico
Pfizer
14Research sites
680Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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).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).
- 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.
Sites
Fundación Respirar
Recruiting
Instituto Argentino de Diagnóstico y Tratamiento - IADT
Recruiting
Hospital Privado de Córdoba
Recruiting
Centro Oncológico de Excelencia - COE San Juan
Recruiting
Sanatorio Británico - Rosario
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Recruiting
Hospital da Criança Santo Antônio
IBCC - Núcleo de Pesquisa e Ensino
Recruiting
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de Controle do Cancer - IBC
Recruiting
Hospital de Clínicas de Passo Fundo
StudyPADL1NK-005
SponsorPfizer
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07144280
