Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer
Condition: NSCLC (Non-small Cell Lung Carcinoma)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ruxolitinib; Placebo; Pemetrexed; Cisplatin
Intervention description: 5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID)); 5 mg matching placebo tablets to be administered by mouth; 500 mg/m^2 administered as an intravenous infusion over 10 minutes; 75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non small cell lung cancer

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.
    

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.