Clinical trial NCT06532006: A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Official title: A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastroesophageal-junction Cancer
Monoclonal Antibody
Gastric Cancer
HER2-positive Gastric Cancer
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
Collaborators: name: Henlius USA
First posted: 2024-08-01
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
timeFrame: Up to 5 years
measure: Overall Survival （OS）
timeFrame: Up to 5 years
Secondary outcomes:
measure: PFS per RECIST 1.1 assessed by investigator
timeFrame: Up to 5 years
measure: Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1
timeFrame: Up to 5 years
measure: Adverse events (AE)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Los Angeles Cancer Network
state: California
city: Los Alamitos
country: United States
facility: OPN - Oncology Physician Network (Los Alamitos)
state: California
city: Brooksville
country: United States
facility: Access Research Institute
state: Florida
city: Deerfield Beach
country: United States
facility: Advanced Research LLC
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center
state: Florida
city: Pompano Beach
country: United States
facility: Napa Research
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine St. Louis
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers Nevada
state: Nevada
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson cancer Center
state: Texas
city: Olympia
country: United States
facility: American Oncology Network Vista Oncology Division
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Cancer Institute
state: West Virginia
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Shijia Zhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: BaiSe
country: China
facility: Affiliated Hospital of Youjiang Medical University for Nationalities
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: BeiJing
country: China
facility: Peking Union Medical College Hospital
city: BengBu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
city: ChangChun
country: China
facility: The First Hospital of Jilin University
city: ChangSha
country: China
facility: Hunan Cancer Hospital
city: ChangZhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
city: ChengDu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: ChongQing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: GuangDong
country: China
facility: Zhongshan City People's Hospital
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
city: HangZhou
country: China
facility: Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medic
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: HeFei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: HeFei
country: China
facility: The Second Hospital of Anhui Medical University
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical University
city: LanZhou
country: China
facility: Gansu Provincial Cancer Hospital
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
city: Lanzhou
country: China
facility: The First Hospital Of Lanzhou University
city: Liuzhou
country: China
facility: Liuzhou Workers' Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science
city: MianYang
country: China
facility: Mianyang Central Hospital
city: NanChang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Renji Hospital,Shanghai Jiao Tong University School of Medicine
city: ShaoYang
country: China
facility: The Central Hospital of Shaoyang
city: Shenyang
country: China
facility: Liaoning Medical University Cancer Institute & Hospital
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Urumqi
country: China
facility: Cancer Hospital Affiliated to Xinjiang Medical University
city: XiaMen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
city: XuZhou
country: China
facility: Xuzhou Central Hospital
city: YiChang
country: China
facility: Yichang Central People's Hospital
city: YinChuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Hiroshima-shi
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Osaki-shi
country: Japan
facility: Osaki Citizen Hospital
city: Saitama City
country: Japan
facility: Saitama Cancer Center
city: Sapporo-shi
country: Japan
facility: Keiyukai Sapporo Hospital
Study officials:
References: