Phase 2 study with nab-Paclitaxel in patients with NSCLC
Research type
Research Study
Full title
A Phase 2, randomized, open-label, multicenter study to assess safety and efficacy of nabpaclitaxel (ABI-007) with epigenetic modifying therapy of CC-486, and nab-paclitaxel monotherapy as second-line treatment in subjects with advanced nonsquamous non-small cell lung cancer (NSCLC): ABOUND.2L
IRAS ID
185323
Contact name
Denis Talbot
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2014-001105-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Summary of Research
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80% of all new cases. At time of diagnosis the majority of patients have inoperable disease and chemotherapy is the standard of care. nab-Paclitaxel is an investigational chemotherapy drug which is being tested in this study as a second line treatment either as monotherapy or in combination with CC-486 (an oral form of azacitidine). Second line therapy is given to patients after their cancer has recurred or is stable after first line treatment for advanced cancer. Despite advances in this research area, the number of available second line treatment options is limited. Therefore patients with advanced NSCLC have an unmet medical need.The purpose of this study is to investigate if nab-paclitaxel when given alone or in combination with CC-486 is safe and effective in treating advanced NSCLC in participants who have already received a first line treatment.
Participants will be assigned in a 1:1 ratio into 1 of 2 treatment groups:
•nab-paclitaxel IV infusion on Days 1 and 8 of every 21 day treatment cycle
•nab- paclitaxel IV infusion on Days 8 and 15 and CC-486 tablets on Days 1 to 14 of every 21 day treatment cycle.Study duration may be 2 years or more, however the average study participation timeframe for a patient is expected to be about 1 year. Participants will visit clinic weekly until progression, followed by a 28 day follow up visit after treatment discontinuation and a survival follow up phone call every 3 months.
Procedures involved include physical exams, vital signs, blood tests, ECGs, CT scans and other investigations that are part of the standard of care.
This study is sponsored by Celgene Corporation. Approximately 160 participants from 30-40 sites will participate. Approximately 40participants will be recruited in the UK
Summary of Results
Lay summary of study results will be provided to the Investigators to pass on to the patients in the form of plain language summary (PLS).REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0521
Date of REC Opinion
27 Oct 2015
REC opinion
Further Information Favourable Opinion