- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04909164
The Prospective Non-randomized Case-control Study From Real-world Lung Cancer Patients (OPTIMUS)
The Prospective Non-randomized Case-control Study to Elucidate Optimal Target Population of Immunotherapy From Real-world Lung Cancer Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Eligible patients are those who receive reimbursed immunotherapy or cytotoxic chemotherapy after failure of platinum-based chemotherapy per current health insurance reimbursement criteria. This study will not provide any additional intervention to patients, but they will receive all treatments available per standard of care at each institution. If the reimbursement criteria change or expand (to include the immunotherapy as the first-line therapy) in the future, patients who get to receive immunotherapy or cytotoxic chemotherapy according to the revised and expanded reimbursement criteria will be enrolled as well.
Because immunotherapy was superior to the existing cytotoxic chemotherapy in terms of survival and AEs in previous large-scale prospective studies, immunotherapy has been preferred than cytotoxic chemotherapy after failure of platinum-based chemotherapy in real-world clinical settings. In addition, pembrolizumab and nivolumab are reimbursed according to PD-L1 expression levels, but atezolizumab is reimbursed for all patients regardless of PD-L1 expression levels and thus is available for reimbursed prescription for practically every patient. These three agents showed almost no difference in their clinical effectiveness in previous prospective global studies. However, cytotoxic chemotherapy is selected over immunotherapy in some patients, and they will be assigned to the control group.
Based on the patient's symptoms and the physician's clinical judgment, cytotoxic therapy can be selected as a second-line therapy in clinical settings if the patient has an extensive lesion that requires inducing a rapid response or has experienced a disease progression centered on bone or liver metastases, which are known to respond only marginally to immunotherapy.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Myung-Ju Ahn, M.D, Ph.D.
- Numéro de téléphone: +82-70-7014-4178
- E-mail: silk.ahn@samsung.com
Sauvegarde des contacts de l'étude
- Nom: Eun-Seo Kim, PM
- Numéro de téléphone: +82-70-7014-4178
- E-mail: eunseo.kim@samsung.com
Lieux d'étude
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Seoul, Corée, République de, 135-710
- Recrutement
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
[Immunotherapy group]
- Male and female patients must be at least 19 years of age.
- Patients with histologically confirmed NSCLC
- Patients on palliative therapy for recurrence after surgery or de novo advanced and metastatic disease
- Patients receiving reimbursed immunotherapy as a second-line therapy (in case of targeted therapy, patients receiving immunotherapy after targeted therapy-platinum-based chemotherapy)
- Patients who provided written informed consent for the study (including the secondary use of the study data and sharing with third parties) [Cytotoxic chemotherapy group]
- Male and female patients must be at least 19 years of age.
- Patients with histologically confirmed NSCLC
- Patients on palliative therapy for recurrence after surgery or de novo advanced and metastatic disease
- Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy
- Patients who provided written informed consent for the study (including the secondary use of the study data and sharing with third parties)
Exclusion Criteria:
[Immunotherapy group]
- Patients receiving immunotherapy without reimbursement
- Patients who do not provide consent to the study [Cytotoxic chemotherapy group]
- Patients receiving cytotoxic chemotherapy without reimbursement
- Patients who do not provide consent to the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Immunotherapy group
Patients receiving reimbursed immunotherapy as a second-line therapy (in case of targeted therapy, patients receiving immunotherapy after targeted therapy-platinum-based chemotherapy)
|
Eligible patients are those who receive reimbursed immunotherapy or cytotoxic chemotherapy after failure of platinum-based chemotherapy per current health insurance reimbursement criteria.
Autres noms:
|
Cytotoxic chemotherapy group
Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy
|
Eligible patients are those who receive reimbursed immunotherapy or cytotoxic chemotherapy after failure of platinum-based chemotherapy per current health insurance reimbursement criteria.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression-free survival
Délai: Up to 3 years
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The time from first dose to disease progression or death from any cause
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Up to 3 years
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Overall-survival
Délai: Up to 3 years
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The time from first dose to death from any cause
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Up to 3 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Response rate
Délai: Up to 3 years
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The proportion of patients showing complete or partial response as determined by RECIST v1.1
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Up to 3 years
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Disease control rate
Délai: Up to 3 years
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The proportion or patients showing complete or partial response or stable disease as determined by RECIST v1.1.
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Up to 3 years
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Duration of response
Délai: Up to 3 years
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The duration of response in patients showing complete or partial response
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Up to 3 years
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Hyper-progression
Délai: Up to 3 years
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The proportion of patients showing hyper-progression after prior treatment according to the criterion for hyper-progression, their survival rate, and predictors of survival
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Up to 3 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Myung-Ju Ahn, M.D, Ph.D., Samsung Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021-02-015
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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