C5851005 - A randomized, phase 3, open-label study to evaluate PF-08046054/SGNPDL1V versus docetaxel in adult participants with previously-treated programmed cell death ligand 1 (PD-Ll) positive non-small-cell lung cancer (NSCLC)

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- 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.
- 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 (eg, estimated glomerular filtration rate (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations).
- Able to provide tumor tissues for biomarker analysis
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
    - 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:
    - Must have received at least 1 approved AGA-targeted therapy
    - 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.

Criteri di esclusione: 

- 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.
- 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 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 Monomethyl auristatin E (MMAE)-containing agent or prior docetaxel.

Numero di pazienti previsti: 

30

Schema di trattamento: 

PF-08046054 monotherapy: Antibody Drug Conjugate. Participants will receive PF-08046054, administered as an IV infusion
Drug: Docetaxel monotherapy: Participants will receive Docetaxel, administered as an IV infusion.

Trattamento sperimentale: 

PF-08046054 Monotherapy (Antibody Drug Conjugate - Other Names: SGN-PDL1V)

Trattamento di controllo: 

Docetaxel monotherapy

Obiettivi primari dello studio: 

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

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-521281-97-00

Data di inserimento: 13.02.2026

Promotore

Pfizer

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -