An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab or Nivolumab plus Platinum Doublet Chemotherapy versus Platinum Doublet Chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

  • STATUS
    Recruiting
  • sponsor
    BMS
Updated on 23 November 2020
lung cancer
nivolumab
cancer chemotherapy
platinum doublet
recurrent non-small cell lung cancer
lung carcinoma

Summary

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab or Nivolumab plus Platinum Doublet Chemotherapy versus Platinum Doublet Chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Description

The main purpose of this study is to see if nivolumab on its own in combination with ipilimumab or in combination with chemotherapy is better at improving your chances of survival and at delaying the worsening of your lung cancer (called progression) when compared to standard chemotherapy treatment. This study will also see how safe and tolerable the study treatments are in patients with advanced non-small cell lung cancer (NSCLC). Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab (Opdivo ™) has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer) and a specific type of previously treated advanced lung cancer. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma.

Details
Condition Non-Small Cell Lung Cancer
Clinical Study IdentifierTX143683
SponsorBMS
Last Modified on23 November 2020

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