Gastric Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer, Monoclonal Antibody
Conditions
Brief summary
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
Detailed description
In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W). In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.
Interventions
DRUGHLX22
HLX22 15mg/kg Q3w
DRUGPembrolizumab
Pembrolizumab 200mg q3w
DRUGTrastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
DRUGOxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
DRUGCapecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Sponsors
Shanghai Henlius Biotech
Henlius USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male/female who are at least 18 years of age on the day of signing the informed consent. 2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. 3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only. 4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor. 5. ECOG PS within 7 days before randomization: 0-1. 6. Expected survival ≥ 6 months. 7. Had adequate organ function
Exclusion criteria
1. Patients with other malignant tumors within 2 years before the randomization. 2. Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. 3. Previous treatment with any HER2-target therapy. 4. Active gastrointestinal bleeding 5. Presence of central nervous system (CNS) metastases. 6. Left ventricular ejection fraction (LVEF) \< 55%. 7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) | Up to 5 years | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm |
| Overall Survival （OS） | Up to 5 years | OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS per RECIST 1.1 assessed by investigator | Up to 5 years | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm |
| Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1 | Up to 5 years | ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1. ORR will be determined for each treatment arm. |
| Adverse events (AE) | Up to 5 years | An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm. |
Countries
Argentina, Australia, Brazil, Chile, China, Georgia, Germany, Greece, Italy, Japan, Peru, Poland, Romania, South Korea, Spain, Turkey (Türkiye), United States
Contacts
CONTACTYing Li
Outcome results
None listed