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NSCLC (Non-small Cell Lung Carcinoma)Phase 2NCT02119650

Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer

A Phase 2 study testing Ruxolitinib, Pemetrexed and Cisplatin in people with NSCLC (Non-small Cell Lung Carcinoma), run by Incyte Corporation at 30 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC (Non-small Cell Lung Carcinoma)
What is being tested?
Ruxolitinib, Pemetrexed and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
30 sitesUnited States
Study dates
11 Feb 2014to 21 Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Study site

    Augusta, Georgia

  • Study site

    Canton, Ohio

  • Study site

    Chattanooga, Tennessee

  • Study site

    Detroit, Michigan

  • Study site

    Fayetteville, Arkansas

  • Study site

    Fresno, California

  • Study site

    Indianapolis, Indiana

  • Study site

    Joliet, Illinois

  • Study site

    Kansas City, Kansas

  • Study site

    Kennewick, Washington

  • Study site

    Knoxville, Tennessee

  • Study site

    La Jolla, California

  • Study site

    Lafayette, Indiana

  • Study site

    Lebanon, New Hampshire

  • Study site

    Leesburg, Virginia

  • Study site

    Lone Tree, Colorado

  • Study site

    Memphis, Tennessee

  • Study site

    Mount Kisco, New York

  • Study site

    New York, New York

  • Study site

    Norwich, Connecticut

  • Study site

    Ogden, Utah

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Reno, Nevada

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Seattle, Washington

  • Study site

    Southington, Connecticut

  • Study site

    St Louis, Missouri

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

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.

Read the 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.

Being tested
Ruxolitinib, Placebo, Pemetrexed, Cisplatin
Keywords
Non small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RuxolitinibDrug

    Also called Jakafi ®, Jakavi ®

    5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID))

  • PlaceboDrug

    5 mg matching placebo tablets to be administered by mouth

  • PemetrexedDrug

    Also called Alimta®

    500 mg/m^2 administered as an intravenous infusion over 10 minutes

  • CisplatinDrug

    75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion

Study groups in NCT02119650
Study groupRoleWhat they receive
Ruxolitinib plus Pemetrexed/CisplatinExperimentalNot described
Receives: Drug: Ruxolitinib; Drug: Pemetrexed; Drug: Cisplatin
Placebo plus Pemetrexed/CisplatinActive comparatorNot described
Receives: Drug: Placebo; Drug: Pemetrexed; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis were censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.

    Measured: Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016.

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum Longest Diameter (LD) recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions or increase in disease burden for subjects with only nonmeasurable disease.

    Measured: Randomization to disease progression, or death due to any cause if sooner; up to 16 months or to the data cutoff 11FEB2016.

  2. Objective Response Rate (ORR)

    Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.

    Measured: Baseline through end of study; up to 16 months or to the data cutoff 11FEB2016.

  3. Duration of Response

    For objective responders, the duration of response is defined as the difference of the end of response and the start of response. The start of a response was the first visit where the subject achieves PR or better based on RECIST v1.1 criteria. The end of response was the first visit after PD based on RECIST v1.1 criteria.

    Measured: From the start of response to the end of response; up to 16 months or to the data cutoff 11FEB2016.

  4. Participants With Treatment-emergent Adverse Events (TEAEs)

    A treatment-emergent AE was defined as an event occurring (or worsening of any pre-existing) after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

    Measured: Baseline through approximately 30 days post treatment discontinuation; up to 16 months or to the data cutoff 11FEB2016.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2014 (estimated)
  2. Study start11 Feb 2014
  3. Primary completion11 Feb 2016
  4. Study completion21 Jun 2016

Why it stopped: The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02119650
Sponsor's protocol ID
INCB 18424-266
Status last verified
Jan 2018
First submitted
17 Apr 2014
Last updated
13 Feb 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib, Pemetrexed and Cisplatin in people with NSCLC (Non-small Cell Lung Carcinoma), run by Incyte Corporation at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02119650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.

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