E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
unresectable stage IIIA/B Non Small Cell Lung Cancer |
tumore del polmone non a piccole cellule stadio IIIA/B non operabile |
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E.1.1.1 | Medical condition in easily understood language |
unresectable stage IIIA/B Non Small Cell Lung Cancer |
tumore del polmone non a piccole cellule stadio IIIA/B non operabile |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062042 |
E.1.2 | Term | Lung neoplasm |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Overall Survival |
sopravvivenza globale |
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E.2.2 | Secondary objectives of the trial |
Progression-free Survival |
sopravvivenza libera da malattia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically or cytologically-confirmed diagnosis of non-small cell lung cancer (NSCLC) – any histology - Age 18-75 - PS 0-1 ECOG - Stage IIIA-B disease (with staging including mandatory CT-PET scan) according to TNM classification judged to be unresectable by a multidisciplinary team including pulmonologists, thoracic surgeons, medical and radiation oncologists - Adequate pulmonary function tests (compatible with thoracic irradiation at full doses) - Signed informed consent
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Tumore del polmone non a piccole cellule (diagnosi cito o istologica), in stadio IIIA-B (TNM) non operabile e candidabile a chemio-radioterapia sequenziale o concomitante ad intento curativo. Criteri di inclusione: - Consenso informato - Età maggiore di 18 anni e minore di 75 anni - Malattia misurabile secondo criteri RECIST - Consenso ad analisi materiale biologico (biopsia tissutale) - Performance status 0-1 - Adeguate funzioni d’organo
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E.4 | Principal exclusion criteria |
1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has a known history of active Bacillus Tuberculosis (TB)
4. Hypersensitivity to pembrolizumab or any of its excipients. 5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 6. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 7. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 8. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or has evidence of interstitial lung disease. 9. Has an active infection requiring systemic therapy. 10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 13. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 15. Has known active Hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or Hepatitis C (e.g., HCV ribonucleic acid [RNA] qualitative is detected). 16. Has received a live vaccine within 30 days of planned start of study therapy.
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- Partecipazione ad altri studi clinici - Diagnosi di immunodeficienza - Anamnesi di infezione tubercolare - Ipersensibilità nota a Pembrolizumab o eccipienti - Pregressa terapia con anticorpi monoclonali a meno di 4 settimane dalla prima somministrazione di Pembrolizumab - Altra neoplasia nota che richieda trattamento attivo - Diagnosi di malattie autoimmuni - Polmonite non infettiva in atto o pregressa trattata con steroidi o evidenza di malattia interstiziale del polmone - Note condizioni mediche che possano in qualche modo precludere la partecipazione allo studio perché confondenti i risultati dello studio stesso o interferire con la partecipazione del soggetto, a discrezione dei ricercatori coinvolti - Comorbidità psichiatriche che precludano l’adesione allo studio/consenso informato - Gravidanza/allattamento - Precedente terapia con agenti anti PD-1 o PD-L1 - Infezione HIV - Infezione epatite B - Vaccinazioni entro 30 giorni dall’inizio del trattamento sperimentale
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E.5 End points |
E.5.1 | Primary end point(s) |
overall survival |
Sopravvivenza globale |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
progression free survival |
sopravvivenza libera da progressione |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
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 | No |
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 |
controllo da pratica clinica |
clinical practice |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |