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Clinical Trial 21652

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT05186974

Phase: Phase II
Principal Investigator: Gray, Jhanelle

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

Summary

The primary objectives of the study are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of SG in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin) in participants with advanced or metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations.

Objective

Primary Objectives * To assess the ORR of SG in combination with pembrolizumab or pembrolizumab + a platinum agent. * Determine the RP2D of SG in combination with pembrolizumab + a platinum agent. Secondary Objectives * To assess the effect of SG in combination with pembrolizumab or pembrolizumab + a platinum agent on the following: PFS as assessed by IRC per RECIST Version 1.1, DOR as assessed by IRC per RECIST Version 1.1, Disease control rate (DCR) as assessed by IRC per RECIST Version 1, and tolerability.

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

Paraplatin (carboplatin); Pembrolizumab (Keytruda); Sacituzumab Govitecan (); carboplatin (); cisplatin ()

Inclusion Criteria

Key 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
  • Other criteria may apply

    • Exclusion Criteria

    Key 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
  • Other criteria may apply

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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