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

• Status: Terminated
• Trial end date: 2016-06-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Cisplatin; Pemetrexed

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.