DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

• ClinicalTrials.gov Identifier: NCT03329690
• Recruitment Status: Completed
• First Posted: November 6, 2017
• Results First Posted: November 27, 2020
• Last Update Posted: March 18, 2022
• Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. )

Study Description

Brief Summary:

The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.

Condition or disease	Intervention/treatment	Phase
Neoplasm, Gastrointestinal	Drug: DS-8201a; Drug: Physician's Choice	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 233 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Two randomized investigative arms will run in parallel (DS-8201a and Physician's Choice), with participants who have disease progression after two previous regimens.

Two non-randomized exploratory arms will run with HER2 treatment-naive participants.

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
• Actual Study Start Date: November 2, 2017
• Actual Primary Completion Date: November 8, 2019
• Actual Study Completion Date: December 11, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Parallel: DS-8201a; Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease has progressed on two prior regimens, will receive DS-8201a once every 3 weeks.	Drug: DS-8201a; DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.; Other Name: Experimental product
Active Comparator: Parallel: Physician's Choice; Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease has progressed on two prior regimens, will receive monotherapy prescribed by the physician before enrollment.	Drug: Physician's Choice; Either: Irinotecan monotherapy (Starting dosage and usage is 150 mg/m2 biweekly, with dose reduction permitted) Paclitaxel monotherapy (Starting dosage and usage is 80 mg/m2 weekly, with dose reduction permitted); Other Name: Standard of Care
Exploratory: Naïve HER2 IHC 2+/ISH-; A maximum of 20 non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every three weeks.	Drug: DS-8201a; DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.; Other Name: Experimental product
Exploratory: Naïve HER2 IHC 1+; A maximum of 20 non-randomized patients with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every 3 weeks.	Drug: DS-8201a; DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.; Other Name: Experimental product

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) [ Time Frame: Baseline to date of first documented objective response (CR or PR), up to 36 months postdose ]
   The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.
2. Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) [ Time Frame: Baseline to date of first documented objective response, up to 36 months postdose ]
   The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported.

Secondary Outcome Measures :

1. Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) [ Time Frame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose ]
   Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause.
2. Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) [ Time Frame: From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose ]
   Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
3. Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) [ Time Frame: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdose ]
   Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
4. Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) [ Time Frame: Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdose ]
   Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
5. Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) [ Time Frame: From randomization to first documented objective response, up to 36 months postdose ]
   The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Independent Central Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported.
6. Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) [ Time Frame: From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdose ]
   Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation.
7. Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) [ Time Frame: From randomization to first documented objective response, up to 36 months postdose ]
   The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) are reported.
8. Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a [ Time Frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) ]
   Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
9. Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a [ Time Frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) ]
   Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
10. Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a [ Time Frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) ]
    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
11. Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a [ Time Frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) ]
    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
12. Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a [ Time Frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) ]
    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The time to maximum serum concentration (Tmax) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
13. Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a [ Time Frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) ]
    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
14. Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) [ Time Frame: Baseline up to 47 days after last dose, up to 36 months postdose ]
    A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
15. Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) [ Time Frame: Baseline up to 47 days after last dose, up to 36 months postdose ]
    A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction
2. Progression on and after at least 2 prior regimens
3. Has an adequate tumor sample
4. Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

Exclusion Criteria:

1. Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
2. Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
3. Has a medical history of clinically significant lung disease
4. Is suspected to have certain other protocol-defined diseases based on imaging at screening period

5. Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:

   1. safety or well-being of the participant or offspring
   2. safety of study staff
   3. analysis of results

Contacts and Locations

Locations

Japan

Aichi Cancer Center Hospital

Nagoya, Aichi, Japan, 464-8681

Hirosaki University Hospital

Hirosaki, Aomori, Japan, 036-8563

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan, 791-0280

Japan Community Health Care Organization Kyushu Hospital

Kitakyushu, Fukuoka, Japan, 806-8501

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan, 373-8550

Kure Medical Center

Kure, Hiroshima, Japan, 737-0023

Hokkaido University Hospital

Sapporo, Hokkaido, Japan, 060-8648

Hyogo Cancer Center

Akashi, Hyogo, Japan, 673-8558

Kansai Rosai Hospital

Amagasaki, Hyogo, Japan, 660-8511

Kobe City Medical Center General Hospital

Kobe, Hyogo, Japan, 650-0047

Ibaraki Prefectural Central Hospital

Kasama, Ibaraki, Japan, 309-1793

Kanazawa University Hospital

Kanazawa, Ishikawa, Japan, 920-8641

Iwate Medical University Hospital

Shiwa-gun, Iwate, Japan, 028-3695

Kagawa University Hospital

Kita, Kagawa, Japan, 761-0793

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan, 216-8511

The Kitasato Institute Kitasato University Hospital

Sagamihara, Kanagawa, Japan, 252-0375

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan, 232-0024

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan, 241-8515

Japanese Red Cross Kyoto Daini Hospital

Kamigyō-ku, Kyoto, Japan, 602-8026

Miyagi Cancer Center

Natori, Miyagi, Japan, 981-1293

Osaki Citizen Hospital

Osaki, Miyagi, Japan, 989-6183

Osaka University Hospital

Suita, Osaka, Japan, 565-0871

Toyonaka Municipal Hospital

Toyonaka, Osaka, Japan, 560-8565

Tochigi Cancer Center

Utsunomiya, Tochigi, Japan, 320-0834

Tokyo Metropolitan Komagome Hospital

Bunkyō-Ku, Tokyo, Japan, 113-8677

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan, 104-0045

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-Ku, Tokyo, Japan, 135-8550

Showa University Koto Toyosu Hospital

Koto-Ku, Tokyo, Japan, 135-8577

Toranomon Hospital

Minato-Ku, Tokyo, Japan, 105-8470

Chiba Cancer Center

Chiba, Japan, 260-8717

Fukui Prefectural Hospital

Fukui, Japan, 910-8526

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan, 811-1395

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Gifu University Hospital

Gifu, Japan, 501-1194

Hiroshima City Asa Citizens Hospital

Hiroshima, Japan, 731-0293

Hiroshima Prefectural Hospital

Hiroshima, Japan, 734-8530

Kochi Health Sciences Center

Kochi, Japan, 781-8555

Niigata Cancer Center Hospital

Niigata, Japan, 951-8566

Okayama University Hospital

Okayama, Japan, 700-8558

Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

Osaka, Japan, 534-0021

Osaka International Cancer Institute

Osaka, Japan, 541-8567

Osaka General Medical Center

Osaka, Japan, 558-8558

Kindai University Hospital

Osaka, Japan, 589-8511

Saitama Cancer Center

Saitama, Japan, 362-0806

Shizuoka Cancer Center

Shizuoka, Japan, 411-8777

Shizuoka General Hospital

Shizuoka, Japan, 420-8527

Keio University Hospital

Tokyo, Japan, 160-8582

Korea, Republic of

Chungbuk National University Hospital

Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644

National Cancer Center

Ilsan, Gyeonggi-do, Korea, Republic of, 10408

Inje University Haeundae Paik Hospital

Busan, Korea, Republic of, 48108

Dong-A University Hospital

Busan, Korea, Republic of, 49201

Kyungpook National University Chilgok Hospital

Daegu, Korea, Republic of, 41404

Chonnam National University Hwasun Hospital

Gwangju, Korea, Republic of, 58128

Gachon University Gil Medical Center

Incheon, Korea, Republic of, 21565

Chonbuk National University Hospital

Jeonju, Korea, Republic of, 54907

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of, 13620

Korea University Anam Hospital

Seoul, Korea, Republic of, 02841

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Yonsei Cancer Center, Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Gangnam Severance Hospital

Seoul, Korea, Republic of, 06273

Samsung Medical Center

Seoul, Korea, Republic of, 06351

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 06591

Chung-Ang University Hospital

Seoul, Korea, Republic of, 06973

Korea University Guro Hospital

Seoul, Korea, Republic of, 08308

Sponsors and Collaborators

Daiichi Sankyo Co., Ltd.

AstraZeneca

Investigators

• Study Director: Global Clinical Leader; Daiichi Sankyo

  Study Documents (Full-Text)

Documents provided by Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. ):

Study Protocol and Statistical Analysis Plan  [PDF] July 3, 2020

More Information

Publications of Results:

Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. doi: 10.1056/NEJMoa2004413. Epub 2020 May 29.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yamaguchi K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Shimoyama T, Lee KW, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Shitara K. Trastuzumab Deruxtecan in Anti-Human Epidermal Growth Factor Receptor 2 Treatment-Naive Patients With Human Epidermal Growth Factor Receptor 2-Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial. J Clin Oncol. 2023 Feb 1;41(4):816-825. doi: 10.1200/JCO.22.00575. Epub 2022 Nov 15.

• Responsible Party: Daiichi Sankyo Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03329690
• Other Study ID Numbers: DS8201-A-J202; 173727 ( Registry Identifier: JAPIC CTI ); DESTINY-G01 ( Other Identifier: Daiichi Sankyo and AstraZeneca )
• First Posted: November 6, 2017
• Results First Posted: November 27, 2020
• Last Update Posted: March 18, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• URL: https://vivli.org/ourmember/daiichi-sankyo/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. ):

Adenocarcinoma Metastatic; Adenocarcinoma of the Stomach; Adenocarcinoma of the Gastroesophageal Junction; HER2 Overexpression; Adenocarcinoma, Locally Advanced; DESTINY - Gastric 01

Additional relevant MeSH terms:

Adenocarcinoma; Gastrointestinal Neoplasms; Digestive System Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Trastuzumab deruxtecan; Immunoconjugates; Immunologic Factors; Physiological Effects of Drugs