Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (DG-03)

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients.

Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Fluorouracil (5-FU); Drug: Trastuzumab deruxtecan; Drug: Capecitabine; Biological: Durvalumab; Drug: Oxaliplatin; Biological: Trastuzumab; Drug: Cisplatin; Biological: Pembrolizumab; Biological: Volrustomig; Biological: Rilvegostomig

• Study Type: Interventional
• Enrollment (Estimated): 413
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Brazil
  • Florianopolis, Brazil, 88020-210
    • Withdrawn
    • Research Site
  • Londrina, Brazil, 86015-520
    • Recruiting
    • Research Site
  • Natal, Brazil, 59075-740
    • Withdrawn
    • Research Site
  • Porto Alegre, Brazil, 90160-093
    • Withdrawn
    • Research Site
  • Ribeirão Preto, Brazil, 14051-140
    • Active, not recruiting
    • Research Site
  • Rio de Janeiro, Brazil, 22793-080
    • Withdrawn
    • Research Site
  • Santa Maria, Brazil, 97015-450
    • Recruiting
    • Research Site
  • Sao Paulo, Brazil, 01509-900
    • Withdrawn
    • Research Site
  • São Jose do Rio Preto, Brazil, 15090-000
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 045202-001
    • Active, not recruiting
    • Research Site
  • São Paulo, Brazil, 03102-002
    • Withdrawn
    • Research Site
• Canada
  • Quebec, Canada, G1J 1Z4
    • Recruiting
    • Research Site
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Withdrawn
      • Research Site
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Withdrawn
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Withdrawn
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Research Site
• China
  • Chengdu, China, 610042
    • Recruiting
    • Research Site
  • Guangzhou, China, 510062
    • Recruiting
    • Research Site
  • Guiyang, China, 550002
    • Recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Withdrawn
    • Research Site
  • Hefei, China, 230001
    • Recruiting
    • Research Site
  • Hefei, China, 230601
    • Withdrawn
    • Research Site
  • Shanghai, China, 200032
    • Recruiting
    • Research Site
  • Shanghai, China, 200031
    • Withdrawn
    • Research Site
  • Shanghai, China, 200050
    • Withdrawn
    • Research Site
  • Urumqi, China, 830000
    • Withdrawn
    • Research Site
  • Wuhan, China, 430000
    • Recruiting
    • Research Site
  • Xiamen, China, 361003
    • Withdrawn
    • Research Site
  • Zhengzhou, China, 450008
    • Active, not recruiting
    • Research Site
• Germany
  • Frankfurt, Germany, 60488
    • Recruiting
    • Research Site
  • Frankfurt, Germany, 60590
    • Recruiting
    • Research Site
  • Hamburg, Germany, 20249
    • Recruiting
    • Research Site
  • Leipzig, Germany, 04103
    • Recruiting
    • Research Site
  • Mannheim, Germany, 68167
    • Recruiting
    • Research Site
  • München, Germany, 81675
    • Recruiting
    • Research Site
• Italy
  • Milano, Italy, 20133
    • Recruiting
    • Research Site
  • Milano, Italy, 20162
    • Recruiting
    • Research Site
  • Napoli, Italy, 80131
    • Recruiting
    • Research Site
  • Padova, Italy, 35128
    • Recruiting
    • Research Site
  • Roma, Italy, 00168
    • Recruiting
    • Research Site
  • Verona, Italy, 37134
    • Recruiting
    • Research Site
• Japan
  • Chuo-ku, Japan, 104-0045
    • Recruiting
    • Research Site
  • Kashiwa, Japan, 277-8577
    • Recruiting
    • Research Site
  • Kita-gun, Japan, 761-0793
    • Recruiting
    • Research Site
  • Ota-shi, Japan, 373-8550
    • Recruiting
    • Research Site
• Korea, Republic of
  • Seongnam-si, Korea, Republic of, 13620
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • Research Site
  • Amsterdam, Netherlands, 1066CX
    • Recruiting
    • Research Site
  • Utrecht, Netherlands, 3584CG
    • Recruiting
    • Research Site
• Poland
  • Gdańsk, Poland, 80-214
    • Recruiting
    • Research Site
  • Konin, Poland, 62-500
    • Recruiting
    • Research Site
  • Koszalin, Poland, 75-581
    • Recruiting
    • Research Site
  • Kraków, Poland, 31-501
    • Recruiting
    • Research Site
  • Lublin, Poland, 20-090
    • Withdrawn
    • Research Site
  • Opole, Poland, 45-061
    • Not yet recruiting
    • Research Site
  • Tomaszów Mazowiecki, Poland, 97-200
    • Recruiting
    • Research Site
  • Warszawa, Poland, 02-034
    • Recruiting
    • Research Site
• Russian Federation
  • Kostroma, Russian Federation, 156005
    • Suspended
    • Research Site
  • Moscow, Russian Federation, 115478
    • Suspended
    • Research Site
  • Moscow, Russian Federation, 143423
    • Suspended
    • Research Site
  • Moscow, Russian Federation, 143442
    • Terminated
    • Research Site
  • Moscow, Russian Federation, 125284
    • Terminated
    • Research Site
  • Novosibirsk, Russian Federation, 630099
    • Suspended
    • Research Site
  • Saint Petersburg, Russian Federation, 195271
    • Completed
    • Research Site
  • Saint-Petersburg, Russian Federation, 197758
    • Suspended
    • Research Site
  • Saint-Petersburg, Russian Federation, 197022
    • Suspended
    • Research Site
  • Sankt-Peterburg, Russian Federation, 196603
    • Suspended
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Research Site
  • Madrid, Spain, 28007
    • Recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Recruiting
    • Research Site
  • Santander, Spain, 39008
    • Recruiting
    • Research Site
  • Sevilla, Spain, 41013
    • Recruiting
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Recruiting
    • Research Site
  • Kaohsiung, Taiwan, 83301
    • Withdrawn
    • Research Site
  • Tainan, Taiwan, 704
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 10002
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 11217
    • Recruiting
    • Research Site
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Research Site
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Research Site
  • Dundee, United Kingdom, DD1 9SY
    • Recruiting
    • Research Site
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • Research Site
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Research Site
• United States
  • California
    • Santa Monica, California, United States, 90404
      • Withdrawn
      • Research Site
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Recruiting
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Research Site
    • Boston, Massachusetts, United States, 02114
      • Withdrawn
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Withdrawn
      • Research Site
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Withdrawn
      • Research Site
  • Texas
    • Houston, Texas, United States, 77090
      • Recruiting
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Withdrawn
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations

2. Disease Characteristics:

   1. Locally advanced, unresectable, or metastatic disease based on most recent imaging
   2. For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results
   3. For Part 3b and 4b, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results
3. For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3 and Part 4, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/ esophagus with with HER2-positive (Part 2 and Part 3 [Arm 3A] and Part 4 [Arm 4A]) or HER2-low (Part 3 [Arm 3B] and Part 4 [Arm 4B])) status
4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1
5. Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function
6. If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.

Exclusion criteria:

1. History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection.
2. Uncontrolled intercurrent illness
3. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
4. Lung-specific intercurrent clinically significant severe illnesses.
5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
7. Has spinal cord compression or clinically active central nervous system metastases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1A; T-DXd and 5-fluorouracil (5-FU)	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a
Experimental: Arm 1B; T-DXd and capecitabine	Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally
Experimental: Arm 1C; T-DXd and durvalumab	Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Biological: Durvalumab; Durvalumab: administered as an IV infusion; Other Names: MEDI4736
Experimental: Arm 1D(b); T-DXd, capecitabine, and oxaliplatin	Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally; Drug: Oxaliplatin; Oxaliplatin: administered as an IV infusion
Experimental: Arm 1E(a); T-DXd, 5-FU, and durvalumab	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Biological: Durvalumab; Durvalumab: administered as an IV infusion; Other Names: MEDI4736
Experimental: Arm 1E(b); T-DXd, capecitabine, and durvalumab	Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally; Biological: Durvalumab; Durvalumab: administered as an IV infusion; Other Names: MEDI4736
Active Comparator: Arm 2A; Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Capecitabine; Capecitabine: administered orally; Drug: Oxaliplatin; Oxaliplatin: administered as an IV infusion; Biological: Trastuzumab; Trastuzumab: administered as an IV infusion; Drug: Cisplatin; Cisplatin: administered as an IV infusion
Experimental: Arm 2B; T-DXd monotherapy	Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a
Experimental: Arm 2E; T-DXd and pembrolizumab	Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Biological: Pembrolizumab; Pembrolizumab: administered as an IV infusion
Experimental: Arm 2C; T-DXd, 5-FU or capecitabine	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally
Experimental: Arm 2D; T-DXd, pembrolizumab and 5-FU or capecitabine	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally; Biological: Pembrolizumab; Pembrolizumab: administered as an IV infusion
Experimental: Arm 2F; T-DXd, pembrolizumab and 5-FU or capecitabine	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally; Biological: Pembrolizumab; Pembrolizumab: administered as an IV infusion
Experimental: Arm 3A; T-DXd, Volrustomig and 5-FU or capecitabine	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally; Biological: Volrustomig; Volrustomig: administered as an IV infusion; Other Names: MEDI5752
Experimental: Arm 3B; T-DXd, Volrustomig and 5-FU or capecitabine	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally; Biological: Volrustomig; Volrustomig: administered as an IV infusion; Other Names: MEDI5752
Experimental: Arm 4A; T-DXd, Rilvegostomig and 5-FU or capecitabine	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally; Biological: Rilvegostomig; Rilvegostomig: administered as an IV infusion; Other Names: AZD2936
Experimental: Arm 4B; T-DXd, Rilvegostomig and 5-FU or capecitabine	Drug: Fluorouracil (5-FU); 5-FU: administered as an IV infusion; Drug: Trastuzumab deruxtecan; T-DXd: administered as an IV infusion; Other Names: DS-8201a; Drug: Capecitabine; Capecitabine: administered orally; Biological: Rilvegostomig; Rilvegostomig: administered as an IV infusion; Other Names: AZD2936

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0	Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0	Safety will be assessed up to the follow-up period, approximately 24 months.
Part 1: Ocurrence of dose-limiting toxicities (DLTs)	Occurrence of dose limiting toxicities	Safety will be assessed up to the follow-up period, approximately 24 months.
Part 1: Changes from baseline in laboratory parameters	Changes in laboratory parameters (every in appropriate units) compared to baseline results.	Safety will be assessed up to the follow-up period, approximately 24 months.
Part 1: Changes from baseline in vital signs	Changes in vital signs results compared to baseline results.	Safety will be assessed up to the follow-up period, approximately 24 months.
Part 1: Changes from baseline in electrocardiogram (ECG) results	Changes in ECG results compared to baseline results.	Safety will be assessed up to the follow-up period, approximately 24 months.
Part 2, Part 3 and Part 4: Endpoint assessed by Investigator per RECIST v1.1: Confirmed Objective Response Rate (ORR)	Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.	(Endpoint: ORR) Efficacy will be assessed at an average of approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Objective Response Rate (ORR)	Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.	Efficacy will be assessed at an average of approximately 12 months
Duration of Response (DoR)	DOR is defined as the time from the date of first documented response until the date of documented progression or death	Until progression or death, efficacy (DoR) will be assessed up to approximately 24 months
Disease Control Rate (DCR)	DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)	Efficacy will be assessed at an average of approximately 12 months
Progression Free Survival (PFS)	PFS is the time from date of first dose until the date of objective disease progression or death	Until progression or death, efficacy (PFS) will be assessed up to approximately 24 months
Overall survival (OS)	OS is the time from date of first dose until death due to any cause	Until death, efficacy (OS) will be assessed up to approximately 24 months
Serum concentration of T-DXd, total anti-HER2 antibody, and MAAA-1181a in all arms	Individual participant data and descriptive statistics will be provided for serum concentration data at each time point for each dose level for T-DXd, total anti-HER2 antibody, MAAA-1181a	While on study drug up to study completion, approximately 24 months
Serum concentration of durvalumab in study arms including T-DXd in combination with durvalumab	Individual participant data and descriptive statistics will be provided for serum concentration data at each time point for durvalumab.	While on study drug up to study completion, approximately 24 months
Comparison of ORR	Comparison of objective response rate between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results	While on study drug up to study completion, approximately 24 months
Comparison of DCR	Comparison of disease control rate between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results	While on study drug up to study completion, approximately 24 months
Comparison of DoR	Comparison of duration of response between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results	While on study drug up to study completion, approximately 24 months
Comparison of PFS	Comparison of progression-free survival between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results	While on study drug up to study completion, approximately 24 months
Comparison of OS	Comparison of overall survival between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results	While on study drug up to study completion, approximately 24 months
Part 2, Part 3 and Part 4: Occurrence of adverse events (AEs) and serious adverse events (SAEs)	Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0	Safety will be assessed up to follow-up period, approximately 24 months
Part 2, Part 3 and Part 4: Changes from baseline in laboratory parameters	Changes in laboratory parameters (every in appropriate units) compared to baseline results.	Safety will be assessed up to follow-up period, approximately 24 months
Part 2, Part 3 and Part 4: Changes from baseline in vital signs	Changes in vital signs results compared to baseline results.	Safety will be assessed up to follow-up period, approximately 24 months
Part 2, Part 3 and Part 4: Changes from baseline in body weight	Changes in body weight in kilograms compared to baseline results.	Safety will be assessed up to follow-up period, approximately 24 months
Part 2, Part 3 and Part 4: Changes from baseline in electrocardiogram (ECG) results	Changes in ECG results compared to baseline results.	Safety will be assessed up to follow-up period, approximately 24 months
Presence of ADAs for T-DXD, durvalumab, volrustomig and rilvegostomig (in study arms including T-DXd and durvalumab, and T-DXd and volrustomig, and T-DXd and rilvegostomig respectively)	Individual participant data and descriptive statistics will be provided for data at each time point for each dose level for T-DXd and durvalumab.	While on study drug up to study completion, approximately 24 months
Serum concentrations of volrustomig and rilvegostomig in study arms including T-DXd in combination with volrustomig and T-DXd in combination with rilvegostomig	Individual participant data and descriptive statistics will be provided for data at each time point for rilvegostomig and volrustomig	While on study drug up to study completion, approximately 24 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Carcinoma; HER2; Gastric Cancer; Adenocarcinoma; Esophageal Cancer; Trastuzumab; Gastroesophageal Cancer; DS-8201a; T-DXd; Deruxtecan
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Immunoconjugates; Trastuzumab; Fluorouracil; Capecitabine; Oxaliplatin; Durvalumab; Pembrolizumab; Trastuzumab deruxtecan
• Other Study ID Numbers: D967LC00001; 2019-004483-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Time Frame: Study start to completion date

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool .

Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.

For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No