Male or female, 18 years or older with histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent. MedDRA version: 17.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malig
Conditions
Interventions
Product Code: INCB039110
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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 3 months 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 3 months 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Run-In Phase (Part 1): • To evaluate the safety and tolerability of INCB039110 in combination with docetaxel and select their doses for further evaluation. Randomized Phase (Part 2): • To evaluate and compare the OS of subjects with previously treated advanced or metastatic NSCLC when treated with INCB039110 in combination with docetaxel versus docetaxel alone. ;Secondary Objective: •To evaluate and compare the efficacy of the 2 treatment groups with respect to PFS. •To evaluate and compare the efficacy of the 2 treatment groups with respect to overall tumor response and duration of response. •To evaluate and compare disease control of INCB039110 in combination with docetaxel versus INCB039110 alone. •To evaluate and compare the safety and tolerability of INCB039110 in combination with docetaxel versus docetaxel alone. ;Primary end point(s): Safety run-in Phase (Part 1) •Safety and tolerability of the treatment regimens through assessment of AEs and changes in safety assessments including laboratory parameters. •Determination of a MTD of INCB039110 in combination with docetaxel. Randomized Phase (Part 2) •Overall survival determined from the date of randomization until death due to any cause. ;Timepoint(s) of evaluation of this end point: The primary endpoint is OS, defined as number of days from randomization to death. Once a total of 69 events has been observed, which is expected after an enrollment period of 12 months, and 5 months of follow-up after the last subject is randomized. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Progression-free survival defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause, if sooner. •Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment. •Safety and tolerability through assessment of AEs and changes in safety assessments and laboratory parameters. •Disease control as measured by the percentage of patients whose best response was not progressive disease (PD) (ie, complete response [CR], partial response [PR], or stable disease [SD] per RECIST v1.1). Stable disease will be included if it occurs at least 6 weeks after randomization. ;Timepoint(s) of evaluation of this end point: Secondary efficacy analysis will be conducted for the intent-to-treat population. Progression-free survival will be determined from the randomization date until the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause if earlier. | — |
Countries
Australia, Canada, European Union, Germany, Hong Kong, Hungary, Ireland, Korea, Republic of, Spain, United States
Contacts
Public ContactInformation Centre
Incyte Corporation
Outcome results
None listed