Informations générales (source: ClinicalTrials.gov)
A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)
Interventional
Phase 3
Daiichi Sankyo (Voir sur ClinicalTrials)
mai 2021
février 2026
25 octobre 2024
This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd)
compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive
gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or
after a trastuzumab-containing regimen and have not received any additional systemic
therapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Michel DUCREUX | 25/03/2024 10:57:10 | 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 Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | 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 | |||||
| Centre Leon Berard - 69373 - Lyon Cedex 08 - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHRU - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU Besançon - 25000 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut de Recherche en Cancerologie de Montpellier IRCM - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| L Institut Mutualiste Montsouris - 75014 - Paris - France | Contact (sur clinicalTrials) | ||||
| Pharmacie ICLN - 42270 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Adults (according to local regulation) and able to provide informed consent for
study participation.
- Pathologically documented gastric and GEJ adenocarcinoma that has been previously
treated in the metastatic setting (unresectable, locally advanced, or metastatic
disease).
- Progression on or after first-line therapy with a trastuzumab or approved
trastuzumab biosimilar-containing regimen. Note: Prior neoadjuvant or adjuvant
therapy with a trastuzumab-containing regimen can be counted as a line of therapy if
the subject progressed on or within 6 months of completing neoadjuvant or adjuvant
therapy. Prior neoadjuvant or adjuvant therapy that does not include trastuzumab
will not be counted as a line of therapy regardless of the progression status of the
subject.
- Locally or centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2
amplification by ISH) as classified by ASCO-CAP on a tumor biopsy obtained after
progression on or after a first-line trastuzumab or approved trastuzumab
biosimilar-containing regimen.
- Eastern Cooperative Oncology Group performance status of 0 or 1 at Screening.
- Adequate bone marrow, renal, hepatic function, and blood clotting function within 14
days of randomization.
- Adults (according to local regulation) and able to provide informed consent for
study participation.
- Pathologically documented gastric and GEJ adenocarcinoma that has been previously
treated in the metastatic setting (unresectable, locally advanced, or metastatic
disease).
- Progression on or after first-line therapy with a trastuzumab or approved
trastuzumab biosimilar-containing regimen. Note: Prior neoadjuvant or adjuvant
therapy with a trastuzumab-containing regimen can be counted as a line of therapy if
the subject progressed on or within 6 months of completing neoadjuvant or adjuvant
therapy. Prior neoadjuvant or adjuvant therapy that does not include trastuzumab
will not be counted as a line of therapy regardless of the progression status of the
subject.
- Locally or centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2
amplification by ISH) as classified by ASCO-CAP on a tumor biopsy obtained after
progression on or after a first-line trastuzumab or approved trastuzumab
biosimilar-containing regimen.
- Eastern Cooperative Oncology Group performance status of 0 or 1 at Screening.
- Adequate bone marrow, renal, hepatic function, and blood clotting function within 14
days of randomization.
- Use of anticancer therapy after trastuzumab-containing treatment
- Medical history of myocardial infarction (MI) within 6 months before
randomization/enrollment, symptomatic congestive heart failure (New York Heart
Association Class II to IV).
- Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to >470 msec
(female subjects) or >450 msec (male subjects) based on average of the Screening
triplicate12-lead ECG.
- Has a history of (non-infectious) interstitial lung disease (ILD/pneumonitis) that
required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis
cannot be ruled out by imaging at Screening.
- Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid
arthritis, Sjögren syndrome, sarcoidosis, etc.) where there is documented (or a
suspicion of) pulmonary involvement at the time of Screening.
- Prior complete pneumonectomy.
- Spinal cord compression or clinically active central nervous system metastases,
defined as untreated and symptomatic or requiring therapy with corticosteroids or
anticonvulsants to control associated symptoms.
- Has multiple primary malignancies within 3 years, except adequately resected
non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors
curatively treated.
- History of severe hypersensitivity reactions to either the T-DXd or inactive
ingredients in T-DXd.
- History of severe hypersensitivity reactions to other monoclonal antibodies,
including ramucirumab or to any of its excipients.
- Known allergy or hypersensitivity to paclitaxel or any components used in the
paclitaxel preparation or other contraindication for taxane therapy.
- Current uncontrolled infection requiring antibiotics, antivirals, or antifungals or
an unexplained fever >38.0°C during Screening visits or on the first scheduled day
of dosing (at the discretion of the Investigator, participants with tumor fever may
be enrolled), which in the Investigator's opinion might compromise the participant's
participation in the study or affect the study outcome
- Clinically significant gastrointestinal disorder (eg, including hepatic disorders,
bleeding, inflammation, occlusion, ileus, diarrhea Grade >1, jaundice, intestinal
paralysis, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease,
or partial bowel obstruction) in the opinion of Investigator
- Has history of receiving live, attenuated vaccine (mRNA and replication deficient
adenoviral vaccines are not considered attenuated live vaccines) within 30 days
prior to the first exposure to study intervention