Phase 2 randomized non-comparative study of Ticilimumab or Best Supportive Care (BSC) immediately folowing 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: 8.0Level: VTcClassification code 10061873
- Registration Number
- EUCTR2006-000568-95-CZ
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Amended Inclusion criteria Numbers 2, 3 and 12
Change From
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.
12 Patients must have received 6 or more cycles or more of first-line treatment. Fewer cycles will be acceptable only in patients achieving a CR in the first-line setting.
12. Must be willing and able to provide written informed consent.
Change To
2. Stage IIIB (locally advanced with effusion) or Stage IV disease at initiation of
platinum-based chemotherapy.
3. Completed first-line platinum-based therapy for non-small cell lung cancer with an
outcome of stable disease or response using RECIST criteria.
12 Patients must have received 4 or more cycles of first-line treatment. Fewer cycles will be acceptable only in patients achieving a CR in the first-line setting.
12. Must be willing 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
Amended Exclusion criteria Numbers 6 and 7
Change From
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..Known active or chronic hepatitis.
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.
Change To
6. Known active or chronic hepatitis.
7. History in the last 5 years of inflammatory bowel disease (eg. Crohn’s disease or
ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>•To evaluate the safety and tolerability of ticilimumab when administered after chemotherapy. <br>•To obtain PK data to be evaluated in a future meta-analysis of ticilimumab pharmacokinetics. <br>•To monitor for human anti-human antibody (HAHA) response to ticilimumab.<br>•To explore whether the CTLA4, FcgammaRIIa and IgG2a genotypes influence the safety, immune response and or efficacy of patients treated with ticilimumab. <br>•To explore Health-Related Quality of Life (HQoL) outcomes.<br>;Primary end point(s): Progression-free survival at 3 months
- Secondary Outcome Measures
Name Time Method