E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Non Small Cell Lung Cancer |
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MedDRA Classification |
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 assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer. Efficacy will be assessed by progression free survival (PFS) at 6 months. |
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E.2.2 | Secondary objectives of the trial |
- To determine the response rate (RR), the time to progression (TTP) and the overall survival (OS); - To confirm the safety of TG4010 administered subcutaneously in combination with chemotherapy in this patient population; - To assess the immunological response; - To explore the plasma proteome profile; - To assess the biological activity of TG4010 by gene expresssion analysis; - To identify transcriptomic patterns or genetic polymorphisms related to NSCLC and/or predictive of the response to treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically confirmed stage IIIB “wet” (with pleural or pericardic effusion) or IV non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma, or large cell carcinoma), positive for MUC1; - No prior systemic treatment for advanced disease; - With at least one measurable lesion evaluated by CT-scan according to WHO critera; - Performance Status 0 or 1 on the ECOG scale; - Minimum estimated life expectancy of 4 months.
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E.4 | Principal exclusion criteria |
- History of any form of systemic therapy for non-small cell carcinoma of the lung except for (neo)adjuvant treatment; - Concomitant brain metastasis; - History of other malignancy in the past 5 years except for basal cell carcinoma and intra-epithelial cervical neoplasia.
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E.5 End points |
E.5.1 | Primary end point(s) |
1/ Efficacy: - Primary endpoint: progression free survival at 6 months (PFS). - Secondary endpoints: response rate (RR) according to WHO criteria, time to progression (TTP) and overall survival (OS).
2/ Safety: Adverse events and serious adverse events.
3/ Immunology: Cellular immune response assessed by tetramer and immunophenotype analysis.
Translational Research: - Proteome analyses by mass spectrometry. - Analysis of changes in peripheral blood gene expression profiles associated with NSCLC, vaccination, immune and/or clinical responses. - Genetic polymorphisms associated with immune and/or clinical responses.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |