AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD0901: Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV
AZD0901: Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)
Ramucirumab+ paclitaxel: Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W
Paclitaxel: Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)
Docetaxel: Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)
Irinotecan: Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W
TAS-102: TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China)
Apatinib: Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)
Study summary
The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) in all randomized participants — From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years).
The analysis will include all randomized participants. All events will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. - Overall Survival (OS) for 3L+ participants — From date of first dose/randomisation until the date of death due to any cause (approximately 3 years).
The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.
Trial sites (158)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Mobile | Alabama | |
| Research Site | Tucson | Arizona | |
| Research Site | Duarte | California | |
| Research Site | Irvine | California | |
| Research Site | Los Angeles | California | |
| Research Site | Los Angeles | California | |
| Research Site | Newport Beach | California | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Hollywood | Florida | |
| Research Site | Orlando | Florida | |
| Research Site | Marietta | Georgia | |
| Research Site | Boise | Idaho | |
| Research Site | Lexington | Kentucky | |
| Research Site | Boston | Massachusetts | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Kansas City | Missouri | |
| Research Site | Mineola | New York | |
| Research Site | New York | New York | |
| Research Site | New York | New York | |
| Research Site | New York | New York | |
| Research Site | Philadelphia | Pennsylvania | |
| Research Site | York | Pennsylvania | |
| Research Site | Charlottesville | Virginia | |
| Research Site | Fredericksburg | Virginia | |
| Research Site | Olympia | Washington | |
| Research Site | Ribeirão Preto | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | Vitória | Brazil | |
| Research Site | Barrie | Ontario | |
| Research Site | London | Ontario | |
| Research Site | North York | Ontario | |
| Research Site | Ottawa | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Montreal | Quebec | |
| Research Site | Beijing | China | |
| Research Site | Changchun | China | |
| Research Site | Chengdu | China | |
| Research Site | Chengdu | China | |
| Research Site | Fuzhou | China |
+ 118 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06346392 on ClinicalTrials.gov ↗ ← All trials in Switzerland