Phase 2 randomized non-comparative study of Ticilimumab or Best Supportive Care (BSC) immediately following first-line platinum-based therapy in patients with stage IIIB (with effusion) or stage IV non-small cell lung carcinoma that has responded or remined stable
- Conditions
- Stage IIIB (with effusion) or IV Non Small Cell Lung CancerMedDRA version: 8.0 Level: VTc Classification code 10061873
- Registration Number
- EUCTR2006-000568-95-GB
- Lead Sponsor
- Pfizer Inc. Laboratoires
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method