Non-small cell lung Cancer (NSCLC)
Conditions
Interventions
Combination chemotherapy paclitaxel/carboplatin/ipilimumab versus
paclitaxel/carboplatin/placebo
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1a) Willing and able to provide informed consent 2a) Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone. 2b) Subjects must present with Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification) 2c) At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area 2d) Eastern Cooperative Oncology Group (ECOG) performance status less or equal than 1 at study entry 2e) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating centers 3a) Men and Women older than or equal to 18 years of age 3b) Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of ipilimumab in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP 3c) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product 3d) Women must not be breastfeeding
Exclusion criteria
Exclusion criteria: 1a) Brain metastases present during screening 1b) Malignant pleural effusion that is recurrent despite appropriate supportive care 1c) Subjects who are known to have activating EGFR mutation 2a) Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppresant treatment such as: Ulcerative colitis and Crohn*s disease, Rheumatoid arthritis, systemic progressive sclerosis (scleroderma), Systemic Lupus Erythematosus, Autoimmune vasculitis (eg, Wegener*s Granulomatosis) 2b) Subjects with history of motor neuropathy considered of autoimmune origin (eg, Guillain Barré Syndrome) 2c) Subjects with a history of toxic epidermal necrolysis (TEN) 2d) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing questionnaires 2e) Serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy 2f) Prior malignancy, active within 5 years, except for locally curable cancers that have been apparently cured and need no subsequent therapy, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast 2g) HIV positive or active Hepatitis B or active Hepatitis C infection 2h) Prior systemic therapy for lung cancer including vaccines and other targeted therapies - Prior radiation therapy or loco-regional surgeries are allowed if performed at least 3 weeks prior to the date of randomization 2i) Subjects with equal or more than Grade 2 peripheral neuropathy 2j) History of allergy or hypersensitivity to any component of the treatment 3a) Inadequate hematologic function defined by: Absolute neutrophil count (ANC) 2.5 times the upper limit of normal (ULN), AST and ALT levels more than 2.5 times the ULN or * 5 times the ULN if liver metastases are present 3c) Inadequate renal function defined as calculated creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To compare Overall Survival (OS) of subjects with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: - Compare overall survival in all randomized subjects who received at least one dose of blinded study therapy (OS2) - Compare Progression-free survival (PFS) per mWHO between the two treatment arms - Compare Best Overall Response Rate (BORR) per mWHO between 2 treatment arms | — |
Countries
Netherlands
Outcome results
None listed