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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04499924

Run by

Seagen Inc.

People needed

17

Starts

2021-03-22

Expected to finish

2024-04-17

Last updated by the study team

2025-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subjects with squamous cell or undifferentiated GEC
• Having received more than 1 line of prior systemic therapy for locally-advanced unresectable or metastatic disease
• Having received taxanes ≤12 months prior to enrollment, prior treatment with ramucirumab, or prior treatment with tucatinib, lapatinib, neratinib, afatinib, or any other investigational anti-HER2 and/or anti-EGFR tyrosine kinase inhibitor, or with T-DM1, T-Dxd, or any other HER2-directed antibody-drug conjugate
• Phase 2 paclitaxel dose optimization stage only: history of prior partial or total gastrectomy
• Unable to swallow pills

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Arizona Cancer Center / University of Arizona — Tucson, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• UCLA Medical Center / David Geffen School of Medicine — Santa Monica, California, United States
• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• Cancer Centers of Colorado - Denver — Denver, Colorado, United States
• SCL Health - St. Mary's Hospital & Medical Center — Grand Junction, Colorado, United States
• SCL Health Good Samaritan Medical Center Cancer Centers of Colorado — Lafayette, Colorado, United States
• Lutheran Medical Center - Cancer Centers of Colorado — Wheat Ridge, Colorado, United States
• Lombardi Cancer Center / Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Holden Comprehensive Cancer Center / University of Iowa — Iowa City, Iowa, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Minnesota Oncology Hematology P.A. — Saint Paul, Minnesota, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic - Taussig Cancer Institute — Cleveland, Ohio, United States
• Oncology Associates of Oregon — Eugene, Oregon, United States
• University of Pennsylvania / Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Tennessee — Knoxville, Tennessee, United States
• Tennessee Oncology-Nashville/Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.