Phase 2 Study of INCB039110 in Recurrent Non-Small Cell Lung Cancer
Research type
Research Study
Full title
A Randomised, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non–Small Cell Lung Cancer
IRAS ID
160523
Contact name
Catherine Hogben
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2013-004812-24
Duration of Study in the UK
1 years, 4 months, 28 days
Research summary
This clinical research study is being sponsored by Incyte Corporation (Sponsor) and the study medication, INCB039110, is being developed for the use in the treatment of Stage IIIb, IV or recurrent Non-Small Cell Lung Cancer.
The main purpose of this study is to find out if the study medication, INCB039110, is safe and has beneficial effects in people who have been previously treated for locally advanced (Stage IIIb), metastatic (Stage IV) or recurrent non-small cell lung cancer (NSCLC), when given in combination with another anticancer therapy, docetaxel.
There are two parts to this study: Part 1 and Part 2. The main purpose of Part 1 of this study is to choose a dose of INCB039110 that is safe and tolerable in combination with docetaxel. The main purpose of Part 2 of this study is to find out if INCB039110 when given in combination with docetaxel will prolong the life of people with Stage IIIb, metastatic (Stage IV) or recurrent NSCLC versus standard treatment with docetaxel alone.
During Part 1 of the study, up to 50 participants will be enrolled in one of two groups (25 participants per group):
• Regimen A: docetaxel administered once every three weeks.
• Regimen B: docetaxel administered weekly for six weeks followed by two weeks of rest.
In Part 2, approximately 100 participants will be enrolled and all will receive docetaxel. Participants may also receive either the study medication or placebo (a non-active drug that will look like the study medication) once a day. The exact dose of study medication or placebo will be based on the results from Part 1 of the study.
This trial is open to patients who have been previously treated for Stage IIIb, IV or recurrent Non-Small Cell Lung Cancer and will be conducted at approximately 50 sites internationally.
Participation is expected to average approximately 5 months.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1192
Date of REC Opinion
19 Dec 2014
REC opinion
Further Information Favourable Opinion