Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA

N/ANot Yet RecruitingNCT07780968

Jazz Pharmaceuticals300 enrolled

Overview

The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA) (HER2+ la/m GEA).

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Esophageal Cancer GastroEsophageal Cancer Gastroesophageal-junction Cancer HER2-positive Gastric Cancer Stomach Cancer

Interventions

ZanidatamabDRUG

Administered via intravenous (IV) infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA 2. Documented plan to initiate a zanidatamab-containing therapy as 1L treatment 3. Sufficient cognitive capacity and language proficiency to complete patient-reported outcomes (PRO) questions 4. 18 years of age or older on the date of initiating 1L zanidatamab-containing therapy Exclusion criteria: 1. Receiving a zanidatamab-containing therapy as part of a clinical trial or expanded access program 2. Received zanidatamab prior to the approval date by the FDA for HER2+ la/m GEA 3. Received the first infusion of zanidatamab prior to providing study consent 4. For patients initiating chemotherapy backbone first, more than 2 months have elapsed before the first dose of zanidatamab

Locations (2)

UCI Health - Chao Family Comprehensive Cancer Center

Orange, California, United States

University of Texas - MD Anderson Cancer Center Gastrointestinal Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Average age of participants

Time frame: Baseline

Patient demographics

The number of participants at each demographic category: sex, race and ethnicity

Time frame: Baseline

Clinical characteristics

Number of participants at each Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities, and gastrointestinal symptoms

Time frame: Baseline

Average BMI

Participants' average body mass index (BMI) in kilogram per square meters

Time frame: Baseline

Average BSA

Participants' average body surface area (BSA) in square meters

Time frame: Baseline

Heart Function

Average Ejection Fraction (EF) and Left Ventricular Ejection Fraction (LVEF) as determined by ECHO or MUGA reported as a percentage

Time frame: Baseline

Diagnostic history

Number of participants at each initial diagnosis stage, TNM (tumor, nodes and metastasis) and clinical staging (metastatic, locally advanced, unresectable), disease subtype (gastric, esophageal or gastroesophageal) and metastatic sites by location

Time frame: Baseline

Treatment history

Treatment history will be defined as the number of participants with previous surgical resection, and adjuvant or neoadjuvant treatments

Time frame: Baseline

Biomarkers

Central Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Incidence of AESI

Incidence of adverse events of special interest (AESI), including diarrhea, associated with programmed cell death protein 1 (PD-1) antagonists

Time frame: Up to 5 years

Duration of the AESI

Duration of the AESI, including the first and subsequent incidence of diarrhea

Time frame: Up to 5 years

Time (by treatment cycle) for the onset of AESI

Time (by treatment cycle) where the onset of AESI and the first and following incidences of diarrhea occurred

Time frame: Up to 5 years

Time (by treatment cycle) of dose adjustment

Time (by treatment cycle) adjustment for chemotherapy, immunotherapy agent or zanidatamab due to diarrhea and AESI

Time frame: Up to 5 years

Number of participants that adhered to prescribed diarrhea prophylaxis

Time frame: Up to 5 years

Time (by treatment cycle) of additional supportive therapy

Time of dose (by treatment cycle) where supportive therapy for AESI and additional therapy for diarrhea was initiated

Time frame: Up to 5 years

Causality of AESI

Number of participants at each category of causality of AESI, including diarrhea

Time frame: Up to 5 years

Resolution of AESI

Number of participants at each category of resolution of AESI, including diarrhea

Time frame: Up to 5 years

Number of participants at each additional supportive therapy

Number of participants that had to initiate additional supportive therapy due to AESI and/or diarrhea

Time frame: Up to 5 years

Number of new metastatic sites

Number of new metastatic site by location

Time frame: Up to 5 years

Real world Objective Response Rate (rwORR)

rwORR is defined as the proportion of participants with a best overall response of Complete Response (CR) or Partial Response (PR) to 1L zanidatamab-containing therapy

Time frame: Up to 5 years

Real world Tumor Response (rwR)

rwR will be reported as real-world complete response (rwCR) which is the proportion of participants with complete clearance of tumor and real-world partial response (rwPR) which is the proportion of participants with reduced tumor burden

Time frame: Up to 5 years

Real world Disease Progression (rwP)

rwP is defined as the proportion of participants with clinician documentation or radiologic evidence of disease worsening

Time frame: Up to 5 years

Real world Progression Free Survival (rwPFS)

rwPFS is defined as the time (in months) from the initiation of 1L zanidatamab-containing therapy until the first occurrence of documented disease progression or death

Time frame: Up to 5 years

Real world Progression Free Survival on Second line Therapy (rwPFS2)

rwPFS2 is defined as the time (in months) from the initiation of 1L zanidatamab-containing therapy until the date of first documented disease progression on the subsequent line of therapy, or death, whichever occurs first

Time frame: Up to 5 years

Real world Duration of Response (rwDoR)

rwDoR is defined as the time (in months) from first real world CR or real world PR to the first documented real world disease progression or death

Time frame: Up to 5 years

Overall survival

Overall survival (OS) is defined as the time (in months) from the initiation of 1L zanidatamab-containing therapy until death

Time frame: Up to 5 years

EORTC IL 66 scores

European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 66 (EORTC IL 66) includes EORTC Item library 19 (EORTC IL 19) and EORTC global health status (GHS)/quality of life (QoL) (EORTC GHS/QoL). EORTC IL 19 is a 5-item scale that assesses the physical functioning domain of health-related quality of life (HRQoL). It has a total score ranging from 0 to 100 with a higher score indicating better level of physical functioning. EORTC GHS/QoL is a 2-item scale with a total score ranging from 0 to 100 with a higher score indicating better level of overall well-being and HRQoL.

Time frame: At Baseline, At Day 15, At 1 month, At 3 months, At 6 months, At 12 months, At 18 months, At 24 months