E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage IIIB (with effusion) or IV Non Small Cell Lung Cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | VTc |
E.1.2 | Classification code | 10061873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal exclusion criteria |
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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free survival at 3 months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
health -related Quality of Life (HQoL) outcomes |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient patients have been recruited and completed the trial as stated in the regulatory application (ie, Clinical Trial Application (CTA)) and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the trial in that Member State. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |