R2810-ONC-16113 Randomized, Phase 3, Open-label Study for NSCLC

• Research type

  Research Study

• Full title

  A Randomized, Phase 3, Open-label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50%

• IRAS ID

  237879

• Contact name

  Samreen Ahmed

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2017-001311-36

• Duration of Study in the UK

  4 years, 2 months, 1 days

• Research summary

  Lung cancer is one of the most commonly diagnosed cancers and is the leading cause of cancer related mortality worldwide. Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancers. With chemotherapy, patients have a median overall survival(OS) of up to 12-18 months and a 5-year survival rate of approx. 18%. REGN2810 is a human monoclonal anti-PD-1 antibody that works by blocking the programmed death-1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells from destroying other cells. Blocking the receptor is expected to help immune cells attack cancer cells. REGN2810 is an investigational drug and is currently not licensed for any indication.
  REGN2810 will be administered every 3 weeks for up to 108 weeks or until disease progression, unacceptable toxicity, initiation of another cancer treatment, withdrawal of consent or for some patients, depending on their response to the drug after at least 6 months.
  Ipilimumab will be administered in combination with REGN2810 as a 50 mg dose by IV infusion over 90 minutes every 6 weeks for up to a total of 4 doses or until disease progression, unacceptable toxicity, initiation of another cancer treatment, or withdrawal of consent.
  Chemotherapy will be administered in repeating cycles (every 3 weeks), either in combination with REGN2810 and ipilimumab for 2 cycles, with REGN2810 for 4 to 6 cycles, or alone for 4 to 6 cycles by IV infusion or until disease progression, unacceptable toxicity , initiation of another cancer treatment, or withdrawal of consent.
  The patient will be assigned by chance to receive standard of care chemotherapy alone, or REGN2810 in combination with standard of care chemotherapy, or REGN2810 in combination with initial standard of care chemotherapy and ipilimumab.
  Patient’s participation will be 1 month of screening, 25 months of treatment plus 7 months of follow-up.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  18/EM/0026

• Date of REC Opinion

  7 Feb 2018

• REC opinion

  Unfavourable Opinion