CompletedPhase 2/3

Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer

United States, Australia, Canada17 participantsStarted 2021-03-22

Plain-language summary

This study is being done to see if tucatinib with trastuzumab, ramucirumab and paclitaxel works better than ramucirumab and paclitaxel to treat HER2-positive (HER2+) cancer of the gut (stomach or gastroesophageal cancer). This study will also look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. Study treatment will be given in 28-day cycles. In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC) * HER2+ disease documented since progression of the most recent line of systemic therapy, as follows: * Phase 2 paclitaxel dose optimization stage: * HER2 amplification in a blood-based NGS assay performed at a central laboratory, or * HER2 overexpression/amplification immunohistochemistry (IHC) and in situ hybridization (ISH) (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample * Phase 2 dose expansion stage: * Cohort 2A: HER2 amplification in a blood-based NGS assay performed at a central laboratory * Cohort 2B: No HER2 amplification by blood-based NGS assay, but HER2 overexpression/amplification by IHC and ISH (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample * Phase 3: HER2 amplification in a blood-based NGS assay performed at a central laboratory * History of prior treatment with a HER2-directed antibody * Progressive disease during or after first-line therapy for locally-advanced unresectable or metastatic GEC * Phase 2: Measurable disease according to RECIST version 1.1 * Phase 3: Measurable or non-measurable disease according to RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Life expectancy of at least 3 months, in the opinion of the investigator Exclusion Criteria: * Subjects with squamous cell or undif…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Dose-limiting Toxicities (DLT) During the First Cycle of Treatment

Timeframe: Cycle 1 (28 days)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)

Number of Participants With Treatment-emergent Laboratory Abnormalities

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)

Number of Participants With Clinically Significant Vital Signs Values

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)

Maximum Percentage Change From Baseline in Weight

Timeframe: From Baseline (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)

Trial details

NCT IDNCT04499924

SponsorSeagen Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-17

Results submitted2024-11-11

View on ClinicalTrials.gov More Gastric Adenocarcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Dose-limiting Toxicities (DLT) During the First Cycle of Treatment

Timeframe: Cycle 1 (28 days)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)

Number of Participants With Treatment-emergent Laboratory Abnormalities

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)

Number of Participants With Clinically Significant Vital Signs Values

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)

Maximum Percentage Change From Baseline in Weight

Timeframe: From Baseline (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)