Randomized Phase II Trial of Docetaxel plus Nivolumab or Docetaxel alone in patients with advanced non-squamous NSCLC and previous clinical benefit on treatment with single agent Nivolumab HCRN LUN15-233

Are you eligible to participate in this study?

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

  • Conditions: lung cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria
ECOG Performance Status of 0-2 within 30 days prior to registration
Histological or cytological confirmed non-squamous non-small cell lung cancer
Measurable disease
Must have has clinical benefit while on single agent nivolumab and now have disease progression
Most recent Nivolumab infusion must be completed within at least 6 weeks of randomization
Mandatory archival tumor tissue mus be identified prior to registration and obtained during the screening period
Mandatory biopsy after registration and prior to C1D1 treatment
Demonstrate adequate organ function
Exclusion Criteria
Prior treatment with Docetaxel
Previous autoimmune complication from Nivolumab requiring discontinuation of therapy or treatment with steroids
Previous discontinuation from Nivolumab due to an adverse event
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L-2, anti-CD-137, or anti-CTLA-4 antibody
Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Pregnant or breastfeeding
Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years
Active central nervous system metastases
Active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications EXCEPT for syndromes which would not be expected to recur in the absence of an external trigger
Test positive for hepatitis B surface antigen or hepatitis C ribonucleic acid
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
History of allergy to study drug components

Recruitment Status


Contact the research team to learn more about this study.

Fields marked with asterisk (*) are required

Please verify that you are not a bot.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Volunteer Sign up

Volunteer Registry

Create your profile and be matched to research opportunities

Register Now!

If you need assistance finding a study or if you have any questions, please email: ctsirro@iu.edu or call us at (317) 278-2176