E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic non-small-cell lung cancer |
Cancer du poumon non à petites cellules métastatique |
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E.1.1.1 | Medical condition in easily understood language |
metastatic non-small-cell lung cancer |
Cancer du poumon non à petites cellules métastatique |
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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 | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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 assess 1-year survival rate in patients treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C) in subjects with advanced NSCLC progressing on first-line chemoimmunotherapy. |
Évaluer le taux de survie globale (OS) à un an chez les patients traités par Tedopi plus docétaxel (bras A) ou Tedopi plus nivolumab (bras B) ou docétaxel en monothérapie (bras C). |
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E.2.2 | Secondary objectives of the trial |
• To assess Overall Survival (OS) • To assess Progression-free survival (PFS) • To assess Objective Response Rate (ORR) • To assess treatment safety Exploratory • To assess correlation of ORR, PFS and OS with biomarkers in tumor tissue or blood. |
- Évaluer la survie globale (OS) - Evaluation de la survie sans progression (PFS) - Évaluer le taux de réponse objective (ORR) - Évaluer la sécurité du traitement Ancillaire - Évaluer la corrélation entre l'ORR, la PFS et la OS avec les biomarqueurs présents dans les tissus tumoraux ou le sang.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female patients willing and able to give written informed consent; 2. Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence of EGFR mutations or ALK or ROS1 rearrangement; 3. Evidence of disease progression at the end of at least 4 cycles of chemoimmunotherapy or 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LA regimen) and eligible for treatment with docetaxel. This criterion implies that patients with immunotherapy primary resistance are excluded; 4. Patients must have experienced progressive disease (PD), either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring after previous clear benefit (any complete –CR- or partial response -PR), or after previous stable disease (SD); 5. Performance status 0-1 (ECOG); 6. Patient compliance to trial procedures; 7. Age = 18 years; |
1. Patients masculins et féminins disposés et en capacité de donner un consentement éclairé écrit ; 2. Diagnostic histologiquement ou cytologiquement confirmé d'un CBNPC HLA-A2+ sans preuve de mutations de l'EGFR ou de réarrangement de ALK ou ROS1 ; 3. Présence d’une progression de la maladie après 4 cycles de chimio-immunothérapie ou de 2 cycles de chimio-immunothérapie suivis de 2 cycles d'immunothérapie (schéma CheckMate9LA) et éligibilité à un traitement par docétaxel. Ce critère implique que les patients présentant une résistance primaire à l'immunothérapie sont exclus ; 4. Les patients doivent avoir présenté une maladie progressive (P), soit pendant ou dans les 3 mois suivant l'arrêt du traitement à base d'anti-PD-(L)1, survenant après un bénéfice clair antérieur (toute réponse complète -RC- ou partielle -RP), ou après une maladie stable antérieure (SD) ; 5. Statut de performance 0-1 (ECOG) ; 6. Compliance du patient aux procédures de l'essai ; 7. Âge ≥ 18 ans ;
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E.4 | Principal exclusion criteria |
1. Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement; 2. No previous chemoimmunotherapy for metastatic disease or evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance). Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded; 3. Patients with intervening systemic therapy following prior anti-PD-(L)1-based therapy; 4. Symptomatic brain metastases. Asymptomatic brain metastases are allowed if not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent); 5. Diagnosis of any other malignancy during the last 3 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumors considered cured; 6. Pregnancy or lactating; |
1. Patient positif pour les mutations de l'EGFR ou le réarrangement de ALK ou ROS1. 2. Absence de chimio-immunothérapie antérieure pour une maladie métastatique ou preuve de progression de la maladie au cours des 4 premiers cycles de chimio-immunothérapie (résistance primaire). Les patients présentant une résistance au traitement (rechute locorégionale et/ou systémique documentée de leur maladie survenant <6 mois après la dernière dose de traitement systémique à base d'anti-PD-(L)1) sont exclus. 3. Les patients ayant reçu un traitement systémique intermédiaire après un traitement antérieur à base d'anti-PD-(L)1. 4. Métastases cérébrales symptomatiques. Les métastases cérébrales asymptomatiques sont autorisées si elles ne nécessitent pas l'utilisation de corticostéroïdes. 5. Diagnostic de toute autre tumeur maligne au cours des 3 dernières années, à l'exception du carcinome in situ du col de l'utérus et du carcinome épidermoïde cutané ou d'autres tumeurs locales considérées comme guéries (par exemple, cancer de la prostate localisé et présumé guéri). 6. Grossesse ou allaitement.
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E.5 End points |
E.5.1 | Primary end point(s) |
1-year Survival Rate |
Taux de survie à un an |
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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) |
• Overall Survival (OS) (1 and 2-year OS) • Progression-free survival (PFS) (1 and 2-year PFS) • Objective Response rate (ORR) • Safety Exploratory • Correlation of ORR, PFS and OS with tumor biomarkers |
- Survie globale (OS) (médiane, OS à 1 et 2 ans) - Survie sans progression (PFS) (PFS à 1 et 2 ans) - Taux de réponse objective (ORR) - Tolérance Ancillaire : - Corrélation de l'ORR, de la PFS et de la OS avec des biomarqueurs dans le tissu tumoral ou le sang.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 and 2 years 1 and 2 years Every 8 weeks Every 3 weeks Exploratory: 48 months |
1 et 2 ans 1 et 2 ans Toutes les 8 semaines Toutes les 3 semaines Exploratoire : 48 mois |
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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 | No |
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 | 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 | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 24 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 36 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 48 |