E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Non-Small Cell Lung Cancer |
Carcinoma polmonare non a piccole cellule |
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E.1.1.1 | Medical condition in easily understood language |
Advanced Non-Small Cell Lung Cancer |
Carcinoma polmonare non a piccole cellule |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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 |
To evaluate the clinical activity of MRTX849 in combination with pembrolizumab administered in the first-line treatment setting to patients having NSCLC with KRAS G12C mutation. |
Valutare l’attività clinica di MRTX849, in combinazione con pembrolizumab, somministrato come trattamento di prima linea a pazienti con NSCLC con mutazione KRAS G12C. |
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E.2.2 | Secondary objectives of the trial |
-To characterize the safety and tolerability of the combination regimen in the selected population. -To evaluate secondary efficacy endpoints using the combination regimen in the selected population. -To evaluate the pharmacokinetics (PK) of MRTX849 administered in combination with pembrolizumab. |
• Caratterizzare la sicurezza e la tollerabilità del regime combinato nella popolazione selezionata. • Valutare gli endpoint di efficacia secondari somministrando il regime combinato nella popolazione selezionata. • Valutare la farmacocinetica (PK) di MRTX849 somministrato in combinazione con pembrolizumab. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and 2. known PD-L1 Tumor Proportion Score (TPS) score. 3.Unresectable or metastatic disease. |
1. Diagnosi confermata istologicamente di tumore polmonare non a piccole cellule (NSCLC) (squamoso o non squamoso) con mutazione G12C del gene KRAS e 2. punteggio noto del punteggio percentuale tumorale (TPS) del ligando della proteina di morte cellulare programmata 1 (PD-L1). 3. Malattia non resecabile o metastatica. |
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E.4 | Principal exclusion criteria |
1.Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, 2. immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510). 3. Active brain metastases. |
1. Precedente trattamento sistemico per NSCLC localmente avanzato o metastatico, tra cui chemioterapia, 2. terapia con inibitori del checkpoint immunitario o terapia mirata alla mutazione G12C del gene KRAS (per es. AMG 510). 3. Metastasi cerebrali attive. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective Response Rate (ORR) |
Tasso di risposta obiettiva (ORR) |
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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) |
-Safety -Blood plasma MRTX849 and potential metabolite concentrations. .Duration of Response (DOR) .Progression-Free Survival (PFS) .1-Year Survival Rate .Overall Survival (OS) |
o Sicurezza o Concentrazioni plasmatiche di MRTX849 e potenziali concentrazioni di metaboliti. o Durata della risposta (DOR) o Sopravvivenza libera da progressione (PFS) o Tasso di sopravvivenza a 1 anno o Sopravvivenza complessiva (OS) |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 |
Canada |
United States |
Italy |
Netherlands |
Spain |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |