| CRITÈRES D'EXCLUSION |
(EN)
- 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.
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