TDXd + Chemotherapy + Pembrolizumab for Gastric Cancer

Recruiting at 30 trial locations

Overseen By Contact for Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Daiichi Sankyo

Must not be taking: HER2-targeting therapies

Disqualifiers: Crohn disease, DPD deficiency, myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 59 months

726 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \<1 gastric or GEJ cancer.

Are You a Good Fit for This Trial?

This trial is for adults with advanced HER2-positive gastric or gastroesophageal junction cancer that hasn't been treated before. They must have a specific protein (PD-L1 CPS ≥1) in the main group, or PD-L1 CPS <1 in another group being studied. Participants need to provide tumor samples and can join even if they had certain treatments over 6 months ago.

Inclusion Criteria

My cancer has a PD-L1 score of 1 or higher.

I meet the required conditions for participation.

My stomach cancer has not been treated and cannot be surgically removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive T-DXd plus fluoropyrimidine plus pembrolizumab or standard of care chemotherapy plus trastuzumab plus pembrolizumab

Up to 59 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Pembrolizumab
• Trastuzumab
• Trastuzumab Deruxtecan

Trial Overview The study tests a combination of TDXd (Trastuzumab Deruxtecan), chemotherapy, and pembrolizumab against standard chemo plus Trastuzumab and pembrolizumab as first-line treatment. It aims to see which mix works better for patients who haven't had prior therapy for their metastatic cancer.

How Is the Trial Designed?

Group I: Main Cohort: Arm M2 Experimental Treatment 3 Interventions

Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) plus pembrolizumab

Group II: Main Cohort: Arm M1 Experimental Treatment 3 Interventions

Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) plus pembrolizumab

Group III: Exploratory Cohort: Arm E2 Experimental Treatment 2 Interventions

Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine)

Group IV: Exploratory Cohort: Arm E1 Experimental Treatment 2 Interventions

Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine)

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University