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 (Protocol CA209370)

Trial ID:
IRB-16-6885
Michael Kosty
The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

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Inclusion Criteria:

  • Histologically confirmed locally advanced or stage IV NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
  • Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria:

  • Untreated or active/progressing Central Nervous system (CNS) metastases
  • Active, known or suspected autoimmune disease
  • Known history of testing positive for HIV or AIDS
  • Active or chronic infection of hepatitis B virus or hepatitis C

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

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