ROVA-T Maintenance in SCLC (MERU)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
IRAS ID
224550
Contact name
Alastair Greystoke
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-003503-64
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Small cell lung cancer (SCLC) currently accounts for about 12% of lung cancers being diagnosed in the UK. Patients with SCLC who are treated with the current standard therapy initially respond well. In many patients the cancer will return leading to an average survival time of 14-20 months in patients with limited stage lung cancer (cancer in one lung) and 9-11 months in patients with extensive stage lung cancer (cancer in both lungs and other parts of the body). This represents a significant unmet medical need.
The standard treatment for all patients with SCLC is currently carboplatin or cisplatin, in combination with either etoposide or irinotecan. This is usually referred to as ‘platinum-based chemotherapy’. Rovalpituzumab tesirine (or Rova-T) is an ‘antibody-drug conjugate’ (ADC) which works by poisoning cancer cells but not normal cells within the lungs. Earlier trials have suggested that if Rova-T is used in patients who have already received treatment for their cancer, it may increase overall survival rate.
In this phase 3 double blind randomised study, 1/2 of patients will receive Rova-T alongside dexamethasone (a corticosteroid that reduces inflammation), and the other 1/2 will receive a placebo. Patients will be able to take part if they have had 4 cycles of standard treatment, and there are no signs of progression. This is therefore a maintenance study. The study will enrol approximately 740 patients at 275 sites worldwide.
Patients will attend regular study visits at the hospital and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on the cancer will be checked by having scans, blood tests, checking for side effects and completing health questionnaires. There are additional blood tests to see why some people respond better than others, and how long the drug remains in the body.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0149
Date of REC Opinion
19 Jun 2017
REC opinion
Further Information Favourable Opinion