Rova-T as 2nd Line Therapy (TAHOE)
Research type
Research Study
Full title
A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)
IRAS ID
228533
Contact name
Fiona Blackhall
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-003726-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 23 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 as a second-line treatment in patients who have already received treatment for their cancer, it may increase overall survival.
In this study, 2/3 of patients will receive Rova-T alongside dexamethasone (a corticosteroid that reduces inflammation). The other 1/3 will receive Topotecan, which is approved for second-line treatment of SCLC. Patients will be able to take part if they have received treatment for their disease but the cancer has progressed either during or after treatment. The study will enrol approximately 411 patients at 225 sites worldwide.
Patients will attend regular study visits at the hospital, but the length of treatment will depend on which drug they are given. 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
London - Brent Research Ethics Committee
REC reference
17/LO/1247
Date of REC Opinion
10 Aug 2017
REC opinion
Favourable Opinion