Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments ruxolitinib, placebo, pemetrexed, cisplatin
Phase phase 2
Targets JAK, JAK1, JAK2
Sponsor Incyte Corporation
Start date March 2014
End date February 2016
Trial size 91 participants
Trial identifier NCT02119650, INCB 18424-266

Summary

The purpose of this study is 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
ruxolitinib Jakafi ®
5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15mg BID or Ruxolitinib 10mg BID)
pemetrexed Alimta®
500 mg/m^2 administered as an intravenous infusion over 10 minutes
cisplatin
75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion
(Active Comparator)
placebo
5 mg matching placebo tablets to be administered by mouth
pemetrexed Alimta®
500 mg/m^2 administered as an intravenous infusion over 10 minutes
cisplatin
75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion

Primary Outcomes

Measure
Part 1: Determination of the dose of ruxolitinib that is safe and tolerable in combination with pemetrexed/cisplatin as measured by the number of dose-limiting toxicities (DLTs) observed in the evaluation cohort.
time frame: Baseline through Day 21
Part 2: Overall Survival (OS)
time frame: Randomization until death due to any cause. Approximately 30 months.

Secondary Outcomes

Measure
Progression-free survival (PFS)
time frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 30 months.
Objective Response Rate
time frame: Baseline through end of study. Approximately 30 months.
Duration of Response
time frame: Baseline through end of study. Approximately 30 months.
Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.
time frame: Baseline through approximately 30 days post treatment discontinuation. Assessed after approximately 30 months.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB Stage IV, or recurrent after prior definitive intervention (radiation, surgery, or chemoradiation therapy, with or without adjuvant or neoadjuvant chemotherapy). - Radiographically measurable or evaluable disease. - Life expectancy of at least 12 weeks. - Tumor without activating driver mutations for which there is available therapy (eg, tumor without mutations in epidermal growth factor receptor or anaplastic lymphoma). - An mGPS of 1 or 2 as defined below: *Criteria: - C-reactive protein >10 mg/L AND albumin ≥35 g/L; Score = 1 - C-reactive protein >10 mg L AND albumin <35 g/L; Score = 2 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit. Exclusion Criteria: - Squamous or mixed histology (eg, adenosquamous) NSCLC - Previous systemic therapy for advanced or metastatic disease. - Known active central nervous system (CNS) metastases. - Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval. - Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure including New York Heart Association functional classification of 3, or arrhythmia requiring treatment. - Uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.

Additional Information

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
Description The study consists of an open-label, safety run-in (consisting of 1 to 4 cohorts of 9 subjects each), to confirm the safety of ruxolitinib in combination with pemetrexed/cisplatin in subjects with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent. Subjects in the safety run-in will receive open-label ruxolitinib and pemetrexed and cisplatin. In the second part of the study, subjects will be enrolled and randomized to receive pemetrexed and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of ruxolitinib administered will be determined from the data produced in the safety run-in phase. Treatment will consist of repeating 21-day cycles. Subjects will receive infusions of pemetrexed and cisplatin on Day 1 of each cycle and ruxolitinib/placebo will be self-administered during the entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed, based on the original treatment assignment, will be allowed for subjects eligible for maintenance therapy.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.
Location data was received from the National Cancer Institute and was last updated in June 2016.