A Phase 2 Study of INCB039110 in combination with docetaxel in advanced Non–Small Cell Lung Cancer

• Conditions: Male or female, 18 years or older with histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, 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 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: EUCTR2013-004812-24-HU
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-10
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

•Male or female, 18 years or older.
•Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV or recurrent.
•mGPS of 1 or 2 as defined below:
•mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin = 35 g/L
•mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L.
•Radiographically measurable or evaluable disease.
•Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease (not including neoadjuvant and/or adjuvant therapy except as noted below).
•Prior systemic regimens must include a platinum based therapy. Investigational agents used in combination with standard platinum therapies are allowed.
•Tumors with driver mutations (EGFR mutation positive or ALK fusion oncogene positive) are allowed provided they also had prior treatment with a tyrosine kinase inhibitor (TKI).
•Maintenance therapy after first-line chemotherapy is allowed provided that the maintenance therapy did not include docetaxel or other taxane.
•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 allowed.
•Prior treatment of advanced or metastatic disease with immune targeted therapy is allowed.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Received prior treatment with a taxane.
•Known active 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 1 month prior to study entry, defined as:
-No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
-Asymptomatic and off all corticosteroids and anticonvulsants for at least 1 month prior to study entry.
•= Grade 3 peripheral neuropathy.
•Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy.
•Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
If the subject has any of the following, they are excluded.
•Absolute neutrophil count < 1.5 × 109/L.
•Platelet count < 100 × 109/L.
•Hemoglobin < 9 g/dL (transfusion are permitted to achieve baseline hemoglobin level.)
•ALT/AST > 2.5 × the upper limit of normal (ULN); or > 5 × ULN in the presence of liver metastases.
•Alkaline phosphatase >2.5 x ULN.
• Subjects with ALT or AST elevation > ULN AND alkaline phosphatase > ULN.
•Total bilirubin > ULN.
•Creatinine clearance <50 mL/min measured or calculated by Cockroft-Gault equation or glomerular filtration rate (GFR) < 50 mL/min/1.73 m2 as calculated using modification of diet in renal disease (MDRD).
•Currently receiving therapy with a potent CYP3A4 inducer or inhibitor. Subjects may enter screening when therapy with the potent inhibitor or inducer is completed and may begin therapy after 1 week or 5 half-lives, whichever is longer.
•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 non-invasive malignancy.

Study & Design

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