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Die klinische Studie NCT06764875 für HER2-positiver Magenkrebs, Adenokarzinom des gastroösophagealen Übergangs ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Eine Phase-III-Studie von Rilvegostomig in Kombination mit Fluoropyrimidin und Trastuzumab Deruxtecan als Erstlinienbehandlung für HER2-positive Gastriskrankheit Phase 3 840 Randomisiert Offene Studie

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Die klinische Studie NCT06764875 untersucht Behandlung im Zusammenhang mit HER2-positiver Magenkrebs, Adenokarzinom des gastroösophagealen Übergangs. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 1. März 2025. Es ist geplant, 840 Teilnehmer aufzunehmen. Durchgeführt von AstraZeneca wird der Abschluss für 9. Dezember 2030 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 9. März 2026 aktualisiert.
Kurzbeschreibung
This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination ...Mehr anzeigen
Ausführliche Beschreibung
The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separat...Mehr anzeigen
Offizieller Titel

A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)

Erkrankungen
HER2-positiver MagenkrebsAdenokarzinom des gastroösophagealen Übergangs
Weitere Studien-IDs
  • D702AC00001
  • 2024-512583-57-00 (Andere Kennung) (EU Clinical Trial Number)
NCT-Nummer
NCT06764875
Studienbeginn (tatsächlich)
2025-03-01
Zuletzt aktualisiert
2026-03-09
Studienende (vorauss.)
2030-12-09
Geplante Rekrutierung
840
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellArm A
T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)
Rilvegostomig
Q3W, intravenous infusion
Trastuzumab deruxtecan
Q3W, intravenous infusion
5-fluorouracil
Q3W, intravenous infusion
Capecitabine
BID, oral administration
Aktives VergleichspräparatArm B
Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
Trastuzumab
Q3W, intravenous infusion
Pembrolizumab
Q3W, intravenous infusion
5-fluorouracil
Q3W, intravenous infusion
Capecitabine
BID, oral administration
Cisplatin
Q3W, intravenous infusion
Oxaliplatin
Q3W, intravenous infusion
Aktives VergleichspräparatArm C
Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
Rilvegostomig
Q3W, intravenous infusion
Trastuzumab
Q3W, intravenous infusion
5-fluorouracil
Q3W, intravenous infusion
Capecitabine
BID, oral administration
Cisplatin
Q3W, intravenous infusion
Oxaliplatin
Q3W, intravenous infusion
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Progression free survival (PFS)
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
Up to approximately 6 years
Overall Survival (OS)
OS is defined as time from randomization until the date of death due to any cause.
Up to approximately 6 years
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Objective Response Rate (ORR)
ORR according to RECIST v1.1. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).
Up to approximately 6 years
Duration of Response (DoR)
DoR according to RECIST v1.1. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 or death due to any cause.
Up to approximately 6 years
Proportion of all randomized participants alive and progression-free at 6 months (PFS6)
Proportion of all randomized participants alive and progression-free at 6 months calculated for progression.
Up to 6 months
Proportion of all randomized participants alive and progression-free at 12 months (PFS12)
Proportion of all randomized participants alive and progression-free at 12 months calculated for progression.
Up to 12 months
Time to second progression or death (PFS2)
PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial progression), after the first subsequent therapy, or death, where the first objective progression includes progression occurring after 2 missed visits.
Up to approximately 6 years
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.
Up to approximately 6 years
Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum
Concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, fluoropyrimidine, and capecitabine in serum or plasma.
Up to approximately 6 years
Immunogenicity of rilvegostomig and T-DXd assessed by the presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd
Presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Up to approximately 6 years
Increase in enteral feeding assistance and eating difficulties
Time to first-confirmed worsening of eating symptoms or initiation of feeding assistance among all participants, as randomized.
Up to approximately 6 years
Proportion of time on study intervention with high side-effect bother
Proportion of time on study intervention with high side-effect bother relative to low side-effect burden as measured by the Patient Global Impression of Treatment Tolerability (PGI-TT).
Up to approximately 6 years
Overall Survival at 12 months (OS12)
Proportion of all randomized participants alive at 12 months.
Up to 12 months
Overall Survival at 24 months (OS24)
Proportion of all randomized participants alive at 24 months.
Up to 24 months
Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum
PK parameters (peak and trough concentrations).
Up to approximately 6 years
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • HER2 positive for gastric cancer on a tumor biopsy.
  • PD-L1 combined positive score (CPS) ≥ 1.
  • Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
  • Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.
  • WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have measurable target disease assessed by the Investigator based on RECIST v1.1.
  • Have adequate organ and bone marrow function within 14 days before randomization.
  • LVEF ≥ 55% within 28 days before randomization.
  • Adequate treatment washout period before randomization.

  • Lack of physiological integrity of the upper gastrointestinal tract.
  • Known dihydropyrimidine dehydrogenase enzyme deficiency.
  • Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.
  • Persistent toxicities caused by previous anti-cancer therapy.
  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
  • Uncontrolled infection including tuberculosis and active hepatitis A infection.
  • Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
  • Recent receipt of live, attenuated vaccine.
  • Chronic/active HBV or HCV infection unless controlled.
  • Clinically significant cardiac or psychological conditions.
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
  • History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Lung-specific intercurrent clinically significant illnesses.
  • Any active non-infectious skin disease requiring systemic treatment.
  • A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).
  • History of any of the following: drug-induced severe cutaneous adverse reaction.
  • Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.
  • Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.
  • Current or prior use of immunosuppressive medication within 14 days before study intervention.
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Kontakt: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
284 Studienstandorte in 28 Ländern
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Research Site, Lima, Lima 34, Peru
Noch nicht rekrutierend
Research Site, Lima, Lima39, Peru
Noch nicht rekrutierend
Research Site, San Isidro, 15073, Peru
Noch nicht rekrutierend
Research Site, Bialystok, 15-027, Poland
Offene Rekrutierung
Research Site, Gdansk, 80-219, Poland
Offene Rekrutierung
Research Site, Koszalin, 75-581, Poland
Offene Rekrutierung
Research Site, Olsztyn, 10-228, Poland
Offene Rekrutierung
Research Site, Przemyśl, 37-700, Poland
Offene Rekrutierung
Research Site, Warsaw, 02-034, Poland
Offene Rekrutierung
Research Site, Wroclaw, 50-556, Poland
Noch nicht rekrutierend
Research Site, Rio Piedras, 00935, Puerto Rico
Offene Rekrutierung
Research Site, Daegu, 41404, South Korea
Offene Rekrutierung
Research Site, Goyang-si, 410-769, South Korea
Offene Rekrutierung
Research Site, Gyeonggi-do, 13620, South Korea
Offene Rekrutierung
Research Site, Jeonnam, 519-763, South Korea
Offene Rekrutierung
Research Site, Seoul, 03080, South Korea
Offene Rekrutierung
Research Site, Seoul, 03722, South Korea
Offene Rekrutierung
Research Site, Seoul, 06351, South Korea
Offene Rekrutierung
Research Site, Seoul, 06591, South Korea
Offene Rekrutierung
Research Site, Seoul, 5505, South Korea
Offene Rekrutierung
Research Site, Badalona, 08916, Spain
Offene Rekrutierung
Research Site, Barcelona, 08035, Spain
Offene Rekrutierung
Research Site, Madrid, 28034, Spain
Offene Rekrutierung
Research Site, Madrid, 28041, Spain
Offene Rekrutierung
Research Site, Ourense, 32005, Spain
Offene Rekrutierung
Research Site, Santander, 39008, Spain
Offene Rekrutierung
Research Site, Seville, 41013, Spain
Offene Rekrutierung
Research Site, Valencia, 46010, Spain
Offene Rekrutierung
Research Site, Kaohsiung City, 80756, Taiwan
Offene Rekrutierung
Research Site, Kaohsiung City, 824, Taiwan
Offene Rekrutierung
Research Site, Taichung, 40447, Taiwan
Offene Rekrutierung
Research Site, Taichung, Taiwan
Offene Rekrutierung
Research Site, Tainan, 704, Taiwan
Offene Rekrutierung
Research Site, Tainan, 736, Taiwan
Offene Rekrutierung
Research Site, Taipei, 100, Taiwan
Offene Rekrutierung
Research Site, Taipei, 112, Taiwan
Offene Rekrutierung
Research Site, Taoyuan District, 333, Taiwan
Offene Rekrutierung
Research Site, Bangkok, 10330, Thailand
Offene Rekrutierung
Research Site, Bangkok, 10400, Thailand
Offene Rekrutierung
Research Site, Bangkok, 10700, Thailand
Offene Rekrutierung
Research Site, Banphaeo, 74120, Thailand
Offene Rekrutierung
Research Site, Dusit, 10300, Thailand
Offene Rekrutierung
Research Site, Khon Kaen, 40002, Thailand
Offene Rekrutierung
Research Site, Muang, 22000, Thailand
Noch nicht rekrutierend
Research Site, Ankara, 06100, Turkey (Türkiye)
Offene Rekrutierung
Research Site, Antalya, 07100, Turkey (Türkiye)
Offene Rekrutierung
Research Site, Diyarbakır, 21280, Turkey (Türkiye)
Offene Rekrutierung
Research Site, Erzurum, 25240, Turkey (Türkiye)
Offene Rekrutierung
Research Site, Istanbul, 34010, Turkey (Türkiye)
Offene Rekrutierung
Research Site, Izmir, 35965, Turkey (Türkiye)
Noch nicht rekrutierend
Research Site, Mezitli, 33200, Turkey (Türkiye)
Offene Rekrutierung
Research Site, Cambridge, CB2 2QQ, United Kingdom
Offene Rekrutierung
Research Site, Coventry, CV2 2DX, United Kingdom
Offene Rekrutierung
Research Site, Dundee, DD1 9SY, United Kingdom
Offene Rekrutierung
Research Site, London, EC1A 7BE, United Kingdom
Offene Rekrutierung
Research Site, London, W1G 6AD, United Kingdom
Offene Rekrutierung
Research Site, Manchester, M20 4BX, United Kingdom
Offene Rekrutierung
Research Site, Sutton, SM2 5PT, United Kingdom
Offene Rekrutierung
Research Site, Hanoi, 100000, Vietnam
Offene Rekrutierung
Research Site, Ho Chi Minh City, 700000, Vietnam
Offene Rekrutierung
Research Site, Hồ Chí Minh, 700000, Vietnam
Offene Rekrutierung
Research Site, Việt Trì, 35000, Vietnam
Offene Rekrutierung
Research Site, Vinh, 460000, Vietnam
Offene Rekrutierung