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Clinical Trial VICCTHO16148

Title

A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination with Atezolizumab Compared with Atezolizumab Alone in Subjects with Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

Principal Investigator(s)

Leora Horn

Details

  • Protocol No. VICCTHO16148
  • Open Date: 05/25/2017
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the overall response rate (ORR) in subjects treated with daratumumab in combination with atezolizumab versus atezolizumab alone.
  • Disease Sites: Lung; Non Small Cell
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Atezolizumab; Daratumumab
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT03023423
  • Secondary Protocol No: 54767414LUC2001

Description

The purpose of this study is to compare the effectiveness of daratumumab in combination with atezolizumab against atezolizumab alone in patients who have advanced non-small cell lung cancer (NSCLC) that has previously been treated. Participants were selected as a possible participant in this study because they have advanced NSCLC and have received one or more types of therapy to treat their disease.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:All
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (Stage IIIb or greater)
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Known PD-L1 tumor status as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained at Screening
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta- hCG]) at Screening within 14 days prior to study drug administration
Inclusion Criteria for Crossover:
• Participants must have been randomized to Arm A of the study and had radiographic disease progression according to RECIST 1.1
• Participants must have a mandatory biopsy at the time of disease progression according to RECIST 1.1 prior to crossing over. If not clinically feasible, discussion with Sponsor is required
• The first dose of atezolizumab in the crossover arm should be within 42 days of last dose but no less than 21 days from the last dose prior to crossing over
Exclusion Criteria:
• Received any of the following prescribed medications or therapies in the past:
1. Anti-cluster of differentiation(CD)38 therapy, including daratumumab
2. CD137 agonists, immune checkpoint inhibitors including but not limited to CTLA-4, anti-PD-1, and anti-PD-L1 therapies
• Known to be seropositive for human immunodeficiency virus (HIV)
• Prior allogeneic bone marrow transplantation or solid organ transplant
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Active hepatitis B, defined by a positive test for hepatitis B surface antigen [HBsAg] or prior history of hepatitis B, defined by presence of antibodies to hepatitis B core antigen [anti-HBc], regardless of hepatitis B surface antibody [anti-HBs] status; active hepatitis C or prior history of hepatitis C (anti-HCV positive), except in the setting of a sustained virologic response (SVR), defined as aviremia 12 weeks after completion of antiviral therapy. If hepatitis C virus (HCV) antibodies are detected, an HCV RNA test for viral load by polymerase chain reaction (PCR) should be performed at least 12 weeks after completion of antiviral therapy to rule out active infection
Exclusion Criteria for Crossover:
• Received any subsequent anti-cancer therapies from the time between the last dose of atezolizumab prior to the first administration of study drug after crossing over
• Whole brain radiation within 28 days or other radiotherapy within 14 days prior to first administration of study drug after crossing over