癌研連線CancerLink
Active, not recruiting NCT05186974

Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

Non-Small Cell Lung CancerPhase 2Stage IIIStage IV

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).

Conditions: Non-small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

  • Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator
  • No prior systemic treatment for metastatic NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate hematologic counts
  • Adequate hepatic function

Exclusion Criteria

  • Mixed SCLC and NSCLC histology
  • Active second malignancy
  • NSCLC that is eligible for definitive local therapy alone
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has had an allogenic tissue/solid organ transplant.
  • Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient
  • Has received radiation therapy to the lung
  • Individuals may not have received systemic anticancer treatment within the previous 6 months
  • Is currently participating in or has participated in a study of an investigational agent
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Known active central nervous system (CNS) metastases
  • History of cardiac disease
  • Active chronic inflammatory bowel disease
  • Active serious infection requiring antibiotics
  • Active or chronic hepatitis B infection
  • Positive hepatitis C antibody
  • Positive serum pregnancy test or women who are lactating

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.