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Last updated: 2023-03-27

2015.12.07 PD-1 Clinical Trial Information

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2015.12.07 PD-1 Clinical Trial Information

2015.12.07 PD-1 Clinical Trial Information

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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.

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PD-1 Clinical Trial Information

  • December 7, 2015
  • Read time: 1 minute

A Phase 3 clinical trial for Stage IV non-small cell lung cancer patients using Nivolumab + Ipilimumab compared with platinum-based chemotherapy. This is a Phase 3 study; if it passes, there is a high probability of it becoming the standard therapy. A total of 1,980 volunteers are being recruited across Japan, the United States, South Korea, Canada, and other countries. Treatment is administered by intravenous injection. Drug names are as follows:

  1. Opdivo
  2. Yervoy

Recruitment period: August 2015 – May 2017

Eligibility criteria:

  1. Age 18 or older
  2. Stage IV non-small cell lung cancer patients
  3. Able to undergo PD-L1 testing
  4. Measurable lesion detectable by RECIST 1.1
  5. Performance Status 0 or 1

Ineligible candidates:

  1. Patients with untreated central nervous system metastases
  2. Patients with immune diseases
  3. HIV-positive patients

The English clinical trial description is as follows:

The purpose of this study is to show that Nivolumab or Nivolumab plus ipilimumab, improves progression free survival and/or overall survival compared with chemotherapy in subjects advanced lung cancer.

Note: Content translated by Medical Supporter is for reference only. Please refer to the following URL for detailed information.

https://www.clinicaltrials.gov/ct2/show/study/NCT02477826

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