A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

  • STATUS
    Recruiting
  • sponsor
    Alliance
Updated on 24 November 2020
lung cancer
nivolumab
cancer chemotherapy
adjuvant chemotherapy

Summary

A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

Description

You are being asked to take part in this research study because you have non-small cell lung cancer, which has been removed by a surgeon. People who are not in a research study are usually offered standard treatment which may include chemotherapy and/or radiation therapy. They are then monitored after treatment in case their cancer returns.

The purpose of this study is to find if adding the study drug, nivolumab (also known as OPVIDO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer. Nivolumab is a drug that may turn on the body’s immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for lung cancer. The study drug, nivolumab, is already FDA-approved for use in non-small cell lung cancer that has previously been treated with chemotherapy. The use of nivolumab in this study is investigational (not approved by the FDA) in your type of cancer.

Details
Condition Non-Small Cell Lung Cancer
Clinical Study IdentifierTX143732
SponsorAlliance
Last Modified on24 November 2020

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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