R2810-ONC-16111,Phase 3,Open Label Pts with Advanced/Metastatic NSCLC
Research type
Research Study
Full title
A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 ≥50%
IRAS ID
241725
Contact name
Samreen Ahmed
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2017-001041-27
Clinicaltrials.gov Identifier
134016, IND Reference
Duration of Study in the UK
3 years, 4 months, 9 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.
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 at least 6 months.
During the first part of the study, a combination of REGN2810 and chemotherapy and ipilimumab or a combination of REG2810 and ipilimumab will be administered. Then REGN2810 will be administered alone for the remainder of the study.
Ipilimumab will be administered in combination with REGN2810 every 6weeks for up to 4 doses until disease progression, unacceptable toxicity, initiation of another cancer treatment, or withdrawal of consent.
Chemotherapy will be administered every 3weeks in combination with REGN2810 and ipilimumab for 2 cycles until disease progression, unacceptable toxicity, initiation of another cancer treatment, or withdrawal of consent.
Pembrolizumab will be administered every 3weeks for up to 108weeks or until disease progression, unacceptable toxicity, initiation of another cancer treatment, or withdrawal of consent.
The patient will be assigned by chance to receive just pembrolizumab, or REGN2810 in combination with ipilimumab, or REGN2810 in combination with ipilimumab plus initial platinum-based doubletchemotherapy during this study.
Participation will be 1month of screening, 25months treatment plus 7months follow-up.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0200
Date of REC Opinion
20 Sep 2018
REC opinion
Further Information Favourable Opinion