NSCLC (Non-small Cell Lung Carcinoma) Clinical Trial
Official title:
A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non-Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent
The purpose of this study was to determine if ruxolitinib, in combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.
The study consisted of an open-label, safety run-in (consisting of 1 to 4 cohorts of 9
participants each), to confirm the safety of ruxolitinib in combination with
pemetrexed/cisplatin in participants with nonsquamous non-small cell lung cancer (NSCLC) that
is Stage IIIB, Stage IV, or recurrent. Participants in the safety run-in received open-label
ruxolitinib and pemetrexed and cisplatin.
In the second part of the study, participants enrolled and randomized and received pemetrexed
and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of
ruxolitinib administered was determined from the data produced in the safety run-in phase.
Treatment consisted of repeating 21-day cycles. Participants received infusions of pemetrexed
and cisplatin on Day 1 of each cycle and ruxolitinib/placebo was self-administered during the
entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed,
based on the original treatment assignment, was allowed for participants eligible for
maintenance therapy.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02257619 -
Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT02298153 -
A Study of Atezolizumab (MPDL3280A) in Combination With Epacadostat (INCB024360) in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma (ECHO-110)
|
Phase 1 | |
| Withdrawn |
NCT02355431 -
Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations
|
Phase 2 |