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A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance after Induction Chemotherapy or as First-Line Treatment Alone or in Combination with Standard of Care Therapies

Study Summary

  • The trial has 5 different groups of patients and your group is determined by things such as your tumor type; such as if you are squamous or non-squamous and also if you have EGFR or ALK mutations.
  •  Once you are identified to one of the groups that will determine your course of treatment. This can be explained further once your group is identified.
  • Each group has different treatment options, but the goal is to look at how Nivolumab, a PDL-1 immunotherapy, works to treat advanced NSCLC either as maintenance or as a first-line treatment.
  • About 1953 people will take part in this research study
  • Study drug will be provided


  • CA209370


  • I/II


  • Dr. Kenneth Blankstein


  • Non-Small Cell Lung Cancer



  • A histologically confirmed (tissue biopsy) of locally advanced or stage IV NSCLC
    • Can be Non-squamous (NSQ) or Squamous (SQ)
  • 18 years of age or older
  • Have not yet started treatment or are currently receiving your first treatment for NSCLC


  • Have carcinomatous meningitis
  • Have active or known autoimmune disease (some exceptions apply). Also have known Hep B or C or ever tested positive for HIV or AIDS
  • Currently taking corticosteroids (> 10 mg daily of prednisone)
  • Had another cancer and have been treated for it in the last year
  • Major surgery or significant traumatic injury in the past 14 days


If you have any questions regarding this study or think that
you or your loved one may be eligible, please feel free to contact: