A Phase 2 Study of Ruxolitinib in Combination With Pemetrexed/Cisplatin and for Treatment of Subjects With Advanced Lung Cancer

• Conditions: onsquamous NSCLC that is Stage IIIB, Stage IV, or recurrent; MedDRA version: 17.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001436-10-ES
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-22
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

-Men or women aged 18 or older.
-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).
-Subjects who have recurrent NSCLC after prior surgery or radiation therapy are allowed to enter. At least 4 weeks must have elapsed between prior radiation therapy and screening, and all radiation therapy?related toxicities must have resolved.
-Subjects who have received radiation to the spine, pelvis, ribs, or femur should be discussed with the sponsor, as extensive radiation to marrow-forming region may compromise a subject's ability to tolerate myelosuppressive chemotherapy.
-Subjects must not have received prior chemotherapy for advanced or metastatic disease.
-An mGPS of 1 or 2 as defined below:
Criteria Score
C-reactive protein > 10 mg/L AND albumin ? 35 g/L1
C-reactive protein > 10 mg/L AND albumin < 35 g/L2
-Radiographically measurable or evaluable disease.
-Life expectancy of at least 12 weeks.
-Tumor without a driver mutation (eg, tumor that is not epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive).
-ECOG performance status of 0 to 1.
-Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit:
-Absolute neutrophil count >= 1.5 × 109/L.
-Platelet count >= 100 × 109/L.
-Hemoglobin >= 85 g/L (transfusion supported is acceptable).
-Alanine aminotransferase and aspartate aminotransferase <=2.5 × upper limit of laboratory normal (ULN) or <=5 × ULN in the presence of liver metastases.
-Total bilirubin <=1.5 × ULN; if total bilirubin is > 1.5 × ULN, then direct bilirubin must be <= 1.5 × ULN.
-Creatinine clearance ? 50 mL/min measured or calculated by Cockroft-Gault equation, or glomerular filtration rate ? 50 mL/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease formula.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening. All female subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening to follow-up.
-Male subjects must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

?Squamous or mixed histology (eg, adenosquamous) NSCLC
?Previous systemic therapy for advanced or metastatic disease. (Subjects who completed a platinum-containing regimen as adjuvant, neoadjuvant, or part of a course of chemoradiation therapy within the 6 months before screening are also excluded.)
?Known active (untreated) central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 4 weeks before study entry, defined as:
?No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
?Asymptomatic and receiving either no or stable doses of anticonvulsants and/or corticosteroids for the 4 weeks prior to study entry.
?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.
?Known hypersensitivity to any of the active substances or any of their excipients, including ruxolitinib, cisplatin, or pemetrexed.
?Inability to take brief courses of dexamethasone each month.
?Unwillingness or inability to take vitamin B12 and folic acid supplements.
?Chronic or current active infectious disease requiring systemic antibiotics, antifungals, or antivirals.
?Known HIV-positive status.
?Hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation. HBV DNA and testing for HCV RNA must be undetectable. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive.
?Pregnant or breastfeeding women.
?Unwillingness to be transfused with blood components
?Prior treatment with any JAK inhibitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified