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

NCT02119650 | Terminated Phase 2 Results DMC

• 1 other identifier: INCB 18424-266
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 30

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.

Conditions

NSCLC (Non-small Cell Lung Carcinoma)

Keywords

Non small cell lung cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Progression-free Survival (PFS)

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

• Objective Response Rate (ORR)

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

• Duration of Response

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

• Participants With Treatment-emergent Adverse Events (TEAEs)

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

Study Arms (2)

Ruxolitinib plus Pemetrexed/Cisplatin

EXPERIMENTAL

Drug: Ruxolitinib; Drug: Pemetrexed; Drug: Cisplatin

Placebo plus Pemetrexed/Cisplatin

ACTIVE COMPARATOR

Drug: Placebo; Drug: Pemetrexed; Drug: Cisplatin

Interventions

Ruxolitinib DRUG

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

Also known as: Jakafi ®, Jakavi ®

Ruxolitinib plus Pemetrexed/Cisplatin

Placebo DRUG

5 mg matching placebo tablets to be administered by mouth

Placebo plus Pemetrexed/Cisplatin

Pemetrexed DRUG

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

Also known as: Alimta®

Placebo plus Pemetrexed/Cisplatin; Ruxolitinib plus Pemetrexed/Cisplatin

Cisplatin DRUG

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

Placebo plus Pemetrexed/Cisplatin; Ruxolitinib plus Pemetrexed/Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (30)

Unknown Facility

Phoenix, Arizona, United States

Location

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Fayetteville, Arkansas, United States

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Fresno, California, United States

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La Jolla, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Lone Tree, Colorado, United States

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Norwich, Connecticut, United States

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Southington, Connecticut, United States

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Augusta, Georgia, United States

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Joliet, Illinois, United States

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Indianapolis, Indiana, United States

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Lafayette, Indiana, United States

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Kansas City, Kansas, United States

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Detroit, Michigan, United States

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St Louis, Missouri, United States

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Reno, Nevada, United States

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Lebanon, New Hampshire, United States

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Mount Kisco, New York, United States

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New York, New York, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Portland, Oregon, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Ogden, Utah, United States

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Leesburg, Virginia, United States

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Kennewick, Washington, United States

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Seattle, Washington, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ruxolitinib; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

855 463-3463

Study Officials

• Gerard T Kennealey, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 22, 2014
• Study Start: February 11, 2014
• Primary Completion: February 11, 2016
• Study Completion: June 21, 2016
• Last Updated: February 13, 2018
• Results First Posted: June 14, 2017

Record last verified: 2018-01

Locations

US (30)