Last updated on November 2018

A Study of Daratumumab in Combination With Atezolizumab Compared With Atezolizumab Alone in Participants With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-Small Cell Lung Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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
  • Tumor cell programmed death-ligand 1 (PD-L1) score as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained after the last line of therapy:
    1. Randomized phase of the study
      1. Participants with a tumor cell PD-L1 score of TC1-3 who are anti-PD-1 or anti-PD-L1 treatment nave will be eligible for screening
    2. Phase 1b (Dara-subcutaneous [SC]+ atezolizumab cohort)
    3. Participants with a tumor cell PD-L1 score of TC0 who are anti-PD-1 or anti-PD-L1 treatment nave will be eligible for screening
    4. Participants who have disease progression on or after anti-PD-1 or anti-PD-L1 therapy and with any tumor cell PD-L1 score (TC0-3) will be eligible for 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. Randomized Phase: Anti-CD38 therapy (including daratumumab), CD137 agonists, and immune checkpoint inhibitors including but not limited to anti-CTLA 4, anti PD-1, and anti-PD-L1 therapies
    2. Phase 1b (Dara-SC + atezolizumab cohort): Anti-CD38 therapy (including daratumumab), CD137 agonists, and immune checkpoint inhibitors with exception of anti-PD-1 or anti-PD-L1 agents
  • 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

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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