A Study of Dinutuximab and Irinotecan for Small Cell Lung Cancer
Research type
Research Study
Full title
A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer
IRAS ID
227441
Contact name
Louise Lim
Contact email
Sponsor organisation
United Therapeutics Corporation
Eudract number
2017-000758-20
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Small cell lung cancer (SCLC) is a disease with a very poor prognosis (5 year survival of only 2% following treatment with combination chemotherapy) and no current significant standard of care.
In this study we are looking at a drug called dinutuximab which is an antibody. Antibodies are substances normally made by special cells in the blood to protect the body from foreign invaders such as bacteria. Dinutuximab sticks to a certain place on SCLC cells where a type of lipid (fat and fat-like substance) called GD2 is present in large amounts. By doing this, dinutuximab may destroy cancer cells. This study will help us compare the effects of the combination of dinutuximab and irinotecan (a type of chemotherapy approved in colorectal cancer) with irinotecan alone to see how it effects survival of patients. As a secondary purpose of the study, we will compare the effects of the combination of dinutuximab and irinotecan with topotecan, another type of chemotherapy. Irinotecan and topotecan are commonly given as single drugs (with no other anticancer medications) to patients with SCLC after it has worsened following initial platinum-based therapy.
The study will recruit 460 pts who have SCLC (which has either relapsed after prior treatment or did not respond to previous treatment) from 200 hospitals around the world with 80 sites in Europe. The study will last around 2.5 years.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1127
Date of REC Opinion
17 Aug 2017
REC opinion
Further Information Favourable Opinion