Patologia: Neoplasie del polmone
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Prima linea
Criteri di inclusione:
- Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
- Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
- Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
- A life expectancy of at least 3 months.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
Criteri di esclusione:
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- Has Grade ≥2 peripheral neuropathy.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
- Received prior systemic anticancer therapy for their metastatic NSCLC.
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
- Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
- Active infection requiring systemic therapy
- Concurrent active Hepatitis B and Hepatitis C virus infection.
- Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's -Disease.
- History of allogeneic tissue/solid organ transplant.
- Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
Trattamento sperimentale:
Pembrolizumab + Sacituzumab tirumotecan
Trattamento di controllo:
Pembrolizumab
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
SC Oncologia Medica 1 - SS Oncologia Medica Toraco Polmonare
Azienda Ospedaliera Santa Maria della Misericordia
Piazzale Santa Maria della Misericordia 15 - 33100 Udine - UD
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Riferimento: Prof. Emilio Bria
Email: emilio.bria@policlinicogemelli.it
Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA
SSD Oncologia Medica per la patologia toracica
Riferimento: Dr. Domenico Galetta
Email: galetta@oncologico.bari.it
Università degli Studi Magna Græcia
Viale Europa - 88100 Germaneto - CZ
AOU Renato Dulbecco - Viale Pio X, 95, Catanzaro
Telefono: 0961883221
Email: oncologia@unicz.it
Numero di iscrizione a registro: 2023-503376-24-00
Data di inserimento: 05.07.2024
Data di aggiornamento: 23.09.2024
Merck Sharp & Dohme LLC
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na