A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

• Research type

  Research Study

• Full title

  A RANDOMIZED, OPEN-LABEL STUDY OF COMBINATIONS OF STANDARD AND HIGH DOSE REGN2810 (CEMIPLIMAB; ANTI-PD-1 ANTIBODY) AND IPILIMUMAB (ANTI-CTLA-4 ANTIBODY) IN THE SECOND-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER

• IRAS ID

  240369

• Contact name

  Clinical Trials Administrator

• Contact email

  clinicaltrials@regeneron.com

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2017-003684-35

• Clinicaltrials.gov Identifier

  NCT03430063

• Clinicaltrials.gov Identifier

  134016, IND number

• Duration of Study in the UK

  2 years, 7 months, 1 days

• Research summary

  Standard or high dose of REGN2810 (anti-PD-1) or REGN2810 in combination with Ipilimumab (anti-CTLA-4), are being investigated for the treatment of advanced or metastatic squamous or non squamous non small cell lung cancer (NSCLC).
  REGN2810 and Ipilimumab monotherapy have not been approved by Regulatory Authorities for treatment of NSCLC.
  In clinical trials, clinical data suggest that anti-PD-1 monotherapy can reduce tumour size, slow tumour growth and may prolong overall survival in participants with NSCLC. Recent clinical trial data demonstrates a higher tumour shrinkage in participants treated with anti-PD-1 plus Ipilimumab compared to anti-PD-1 monotherapy alone.

  This global study is planned to recruit approximately 201 participants and will collect information on how participant’s NSCLC responds to treatment.
  Participation in the study may last up to 32 months. The study is divided into four periods;
  • Screening Period - a period of up to 28 days to check eligibility
  • Treatment period - a period of approximately 25 months (108 weeks) of study drug treatment
  • Follow-up period - a period of approximately 6 months following study drug treatment
  • Survival Follow-up period - once treatment and follow-up portions of the study are completed, participants will be contacted by phone every 3 months (quarterly) for information regarding their disease status and if they are receiving any other cancer treatments. Participation in survival follow-up will last until the final study participant completes the final follow-up study visit or discontinues early, or until informed consent is withdrawn.

  Study procedures will be performed within these periods; however before any study procedures are undertaken Informed Consent will be required. At scheduled study visits, participants will visit the research centre where study assessments will take place e.g. physical exam, blood tests and body scans. Side effects will be monitored throughout the study for safety.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  18/YH/0165

• Date of REC Opinion

  8 Jun 2018

• REC opinion

  Further Information Favourable Opinion