N3
Research type
Research Study
Full title
A PHASE I/II TRIAL OF COMBINATION NAB-PACLITAXEL AND NINTEDANIB OR NAB-PACLITAXEL AND PLACEBO IN RELAPSED NSCLC ADENOCARCINOMA
IRAS ID
199962
Contact name
Aude Espinasse
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2016-000109-35
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
Lung cancer is the second most common cancer in the UK and the commonest cause of cancer related deaths in men and women. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Majority of patients with NSCLC relapse after first line treatment. Treatment options for patients with relapsed NSCLC are limited and prognosis is poor. These patients tend to tolerate systemic treatment less well with higher incidence of complications requiring treatment modification, interruption or discontinuation. This is a trial of a novel combination of chemotherapy agent nab-paclitaxel with an oral anti-angiogenesis inhibitor nintedanib.
Nab-paclitaxel, nanoparticle-albumin-bound paclitaxel, has been developed to improve the therapeutic index of paclitaxel. It has been shown to have an improved toxicity profile compared to solvent-bound paclitaxel and docetaxel in breast and lung cancer patients. Nab-paclitaxel is approved in Europe and US for the treatment of first line advanced NSCLC in combination with carboplatin and has shown single agent activity in relapsed NSCLC, comparable to other approved second line chemotherapy agents.
Nintedanib is a small molecule tyrosine kinase inhibitor targeting cell surface receptors involved in new blood vessel formation (angiogenesis) within the tumour and thereby tumour growth and metastasis. Anti-angiogenic agents have been shown to improve efficacy in both first line and relapsed NSCLC when added to chemotherapy. Nintedanib is licenced for use in the second line in patients with relapsed NSCLC adenocarcinoma in combination with docetaxel.
The recommended phase 2 dose (RP2D) of nintedanib given with nab-paclitaxel is unknown and the efficacy of the combination has not been investigated to date. This trial is designed in two parts: Phase Ib to idenitify the RP2D of nintedanib in combination with nab-paclitaxel; and Phase II where eligible patients will be randomised in a 1:1 fashion to receive nab-paclitaxel with nintedanib or nab-paclitaxel with placebo.REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0427
Date of REC Opinion
8 May 2017
REC opinion
Further Information Favourable Opinion