Stage IIIB (with effusion) or IV Non Small Cell Lung Cancer MedDRA version: 8.0 Level: VTc Classification code 10061873
Conditions
Interventions
Product Name: Ticilimumab
Product Code: CP-675,206
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ticilimumab
CAS Numbe
Sponsors
Pfizer Inc. Laboratoires
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically proven NSCLC. 2.Stage IIIB (locally advanced with effusion) or Stage IV disease. 3.Completed first-line platinum-based therapy for non-small cell lung cancer with an outcome of stable disease or response using RECIST criteria. Patients must have received 6 cycles of first-line treatment. Fewer cycles will be acceptable only in patients achieving a CR in the first-line setting 4.Able to be randomized between 3 weeks after and no more than 6 weeks after the last dose of platinum-based treatment. 5.Patients with stable disease or a partial response following first-line treatment must have measurable disease according to RECIST. 6.Male or female, 18 years of age or older. 7.ECOG performance status 0-1. 8.Adequate bone marrow, hepatic and renal function determined within 14 days prior to enrollment, defined as in the enclosed study protocol. 9.Patients must have recovered from all prior treatment-related toxicities to baseline status or to NCI CTCAE (v 3.0) Grade of 0 or 1 except for toxicities not considered a safety risk such as alopecia or residual peripheral neuropathy resulting from prior systemic therapy. 10.Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to randomization. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential. 11.Females of childbearing potential who have not undergone surgical sterilization must agree to practice a form of effective contraception prior to entry into the study and for 12 months following the last dose of study drug. The definition of effective contraception will be based on the judgment of the investigator. 12.Must be willing and able to provide written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Greater than 6 weeks between last dose of first-line chemotherapy and date of randomization. The last dose of first-line chemotherapy must have been administered at least 3 weeks prior to randomization. 2.Other systemic therapy for NSCLC since last dose of first-line chemotherapy. 3.Previous treatment with bevacizumab or other anti-CTLA4 agents (eg, MDX 010). 4.Symptomatic or uncontrolled brain metastases or uncontrolled pleural effusions. 5.History of chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.). Psoriasis that is current or active in the last 3 years. Active vitiligo or a history of vitiligo will not be a basis for exclusion. 6.History of chronic hepatitis due to Hepatitis C or Hepatitis B virus or current evidence of acute hepatitis due to Hepatitis C or Hepatitis B virus.. 7.History in the last 5 years of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin. 8.Received an immunosuppressive dose of corticosteroids or other immunosuppressive medication (eg, methotrexate, rapamycin) within 4 weeks of enrollment. Note: Patients with adrenal insufficiency may take up to 5 mg of prednisone or equivalent daily. Topical and inhaled corticosteroids in standard doses are allowed. 9.Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 10.Any serious, uncontrolled medical disorder or active infection that would impair the ability to receive study treatment. 11.Diagnosis of any second malignancy within the last 3 years except basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrent disease for 12 months. 12.Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the progression free survival rate at 3 months in patients with locally advanced or metastatic NSCLC treated with ticilimumab or best supportive care immediately following first line platinum based treatment with an outcome of response or stable disease; Secondary Objective: • To assess additional evidence of anti tumor activity as measured by objective response rate, progression free survival, overall survival and 1 year survival. • To evaluate the safety and tolerability of ticilimumab when administered after chemotherapy. •To obtain PK data to be evaluated in a future meta-analysis of ticilimumab pharmacokinetics. •To monitor for human anti-human antibody (HAHA) response to ticilimumab. •To explore whether the CTLA4, FcgammaRIIa and IgG2a genotypes influence the safety, immune response and or efficacy of patients treated with ticilimumab. •To explore Health-Related Quality of Life (HQoL) outcomes. ;Primary end point(s): Progression-free survival at 3 months | — |
Countries
Czech Republic, United Kingdom
Outcome results
None listed