A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy

Study Status

Open to Enrollment

Study Description

The purpose of this study is to determine the safety and effectivenes of the experimental therapy ramucirumab in patients with Stage IV or advanced Non-Small Cell Lung Cancer.

Ramucirumab is a humanized monocloncal antibody against VEGFR-2, an important receptor in a tumor's vessel growth and something needed to supply oxygen and nutrients to the tumor. In laboratory studies, ramucirumab has been shown to enhance the effects of chemotherapy.

The study will help determine whether ramucirumab can help lung cancer patients live longer when it is given with another chemotherapy treatment called docetaxel.

All patients will receive docetaxel, the standard treatment for Non-Small Cell Lung Cancer. Patients will be randomized into one of two study groups:

  • Arm A, Ramucirumab and docetaxel: patients receive ramucirumab infusion followed by docetaxel infusion on Day 1 of every 3-week cycle
  • Arm B, Placebo and docetaxel: placebo infusion, followed by docetaxel infusion on Day 1 of every 3-week cycle

Patients will receive treatment until their tumor starts worsening. The average time of treatment with docetaxel alone at this stage of the disease is 4 cycles, or approximately 12 weeks. Patients who receive ramucirumab may be followed longer.

Disease Status and/or Stage

Stage IV Non-Small Cell Lung Cancer



Key Eligibility

  • Men and women age 18 and older
  • Stage IV Non-Small Cell Lung Cancer
  • Disease progression during or after first platinum-based chemotherapy regimen with or without maintenance therapy for advanced/metastatic disease
  • Not more than 1 prior chemotherapy regimen
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Bryan Schneider, MD


  • Physician's office
  • (646) 962-2066

Healthy Volunteers


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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