Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Stage I-III Limited Disease Small-Cell Lung Cancer Who Have Not Progresse

    Cancer Categories
    • Lung
    Karmanos Trial ID
    • 2018-111
    NCT ID
    • NCT03703297
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator

    Objective:

    Primary Objective:
    • To assess the efficacy of durvalumab monotherapy as well as durvalumab in combination with tremelimumab therapy compared to placebo in terms of PFS
    • To assess the efficacy of durvalumab in combination with tremelimumab therapy compared to placebo in terms of OS
    Secondary Objectives:
    • To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS
    • To further assess the efficacy of durvalumab monotherapy and durvalumab and tremelimumab combination therapy compared to placebo in terms of ORR, PFS18a, PFS24a, TTDM, OS24, OS36, and PFS2
    • To assess the efficacy of durvalumab and tremelimumab combination therapy compared to durvalumab monotherapy in terms of PFS, OS, and ORR
    • To assess disease-related symptoms and HRQoL in patients treated with durvalumab monotherapy or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-C30 v3 and QLQ-LC13
    • To assess the PK of durvalumab monotherapy and durvalumab and tremelimumab combination therapy
    • To investigate the immunogenicity of durvalumab monotherapy and durvalumab and tremelimumab combination therapy
    • To investigate the relationship between a patient’s tumor mutational burden (TMB) measured in tumor and/or blood and efficacy outcomes with durvalumab and durvalumab and tremelimumab combination therapy
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266