Informations générales (source: ClinicalTrials.gov)
A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation
Interventional
Phase 3
Dizal Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2022
octobre 2027
05 avril 2025
This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and
safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally
advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or
have not received prior systemic therapy in advanced stage.
Primary objective of this study is to assess the efficacy of DZD9008 versus
platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary
endpoint. Approximately 320 participants are estimated to be randomized into the study.
Participants enrolled will be randomized to DZD9008 or platinum-based doublet
chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Jaafar BENNOUNA | 07/04/2025 07:02:30 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bichat | Zalcman | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | WISLEZ | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Cadranel | Contact (sur clinicalTrials) | |||
| CHI DE CRETEIL | Monnet | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Naltet | Contact (sur clinicalTrials) | |||
| HIA BEGIN | Picci | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM-Hôpital NORD - Marseille - France | Greillier | Contact (sur clinicalTrials) | |||
| Centre de Cancérologie Montpellier - Montpellier - France | Becht-Rolly | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire d'Angers - Angers - France | Oulkhouir | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Albert Calmette - Clinique des Maladies Respiratoires - Hellemmes-Lille - France | Cortot | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Saint Herblain - France | Pons Tostivint | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon - La Tronche - France | Moro-Sibilot | Contact (sur clinicalTrials) | |||
| CHU Poitiers - Poitiers - France | Lamour | Contact (sur clinicalTrials) | |||
| Hopital Foch - Suresnes - France | Bennouna-Louridi | Contact (sur clinicalTrials) | |||
| Hôpital Louis Pradel - Bron - France | Pierret | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de L'Ouest - Saint Herblain - France | Doucet | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Aged at least 18 years old (or per local regulatory/IRB requirement).
2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally
advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging
criteria) or metastatic (Stage IV), not suitable for curative therapy.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20
insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function
1. Aged at least 18 years old (or per local regulatory/IRB requirement).
2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally
advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging
criteria) or metastatic (Stage IV), not suitable for curative therapy.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20
insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function
1. Prior treatment with any systemic anti-cancer therapy for locally advanced or
metastatic NSCLC.
2. Spinal cord compression or leptomeningeal metastasis.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of stroke or intracranial hemorrhage within 6 months before randomization.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic
diseases, including uncontrolled hypertension and active bleeding diatheses (i.e.,
hemophilia and Von Willebrand disease).