Clinical trial NCT02119650: Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: NSCLC (Non-small Cell Lung Carcinoma)
Keywords: Non small cell lung cancer
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 modified Glasgow Prognostic Score (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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016.
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Randomization to disease progression, or death due to any cause if sooner; up to 16 months or to the data cutoff 11FEB2016.
measure: Objective Response Rate (ORR)
timeFrame: Baseline through end of study; up to 16 months or to the data cutoff 11FEB2016.
measure: Duration of Response
timeFrame: From the start of response to the end of response; up to 16 months or to the data cutoff 11FEB2016.
measure: Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline through approximately 30 days post treatment discontinuation; up to 16 months or to the data cutoff 11FEB2016.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Lone Tree
country: United States
state: Colorado
city: Norwich
country: United States
state: Connecticut
city: Southington
country: United States
state: Connecticut
city: Augusta
country: United States
state: Georgia
city: Joliet
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lafayette
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Detroit
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Reno
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: Mount Kisco
country: United States
state: New York
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Chattanooga
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Ogden
country: United States
state: Utah
city: Leesburg
country: United States
state: Virginia
city: Kennewick
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Incyte Corporation
name: Gerard T Kennealey, MD
role: STUDY_DIRECTOR
References: