Study comparing the efficiacy of experimental drug, Plinabulin, with docetaxel verses docetaxel with placebo in patients with non small cell lung cancer with at least 1 large lesion.

What we are studying

The purpose of the study is to compare the effects, good and or bad, of one drug against another drug. This large multi-country study assesses an experimental (investigational) anti-cancer drug called plinabulin (BPI-2358) and a marketed anti-cancer drug call docetaxel (Taxotere®). In this study, Plinabulin combined with Docetaxel will be compared to Docetaxel with a placebo. This is a Phase 3 study which means that there is a fair amount information already available on the safety and efficacy of this compound and the study is being done in order to confirm the treatment effect learned from smaller scale studies done previously. The specific purposes of this study are to compare survival, tumor shrinkage, tumor regrowth and side effects in patients with lung cancer treated with docetaxel to patients treated with docetaxel and plinabulin.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Subject has squamous or non-squamous NSCLC
  • Has previously failed first treatment therapy
  • At least 1 large lesion greater than or equal to 3 cm
  • Life expectancy more than 12 weeks
  • Willing and able to give written consent
  • Cannot be diagnosed with HIV
  • Or active hepatits A
  • B or C
  • Cannot be pregnant or breatfeeding
  • Cannot have second malignancy (unless in remission for greater than 5 years)

What is involved

  • CT scans
  • Medical history review
  • Vital signs
  • Physical examination
  • Baseline pregnancy test
  • Tumor biopsy (if sample is not previously prepared)
  • Baseline brain scan
  • 4 quality of life questionnaires
  • Lab assessments at each visit
  • Drug infusions

Compensation

None

Contact Information

Study Coordinator
Sharon Averill, RN, CCRP
Email
saver[email protected]
Phone
-6925
Principal Investigator
Jimmy Ruiz, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.