Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma

NCT07700979
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
900
clinicaltrials.gov
Lead sponsor
Akeso
clinicaltrials.gov
Start date
2026-09-24
clinicaltrials.gov
Number of sites
25
clinicaltrials.gov

Summary
The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma trial is to compare OS between cadonilimab combined with chemotherapy and chemotherapy in combination with or without nivolumab in the ITT population.
clinicaltrials.gov
Acronym
G/GEJ
clinicaltrials.gov
Short title
Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma
clinicaltrials.gov
Official title
A Randomized, Double-blind, Multi-regional Phase 3 Study of Cadonilimab Combined With Chemotherapy Versus Chemotherapy in Combination With or Without Nivolumab for the First-line Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2030-08-18
clinicaltrials.gov
First posted
2026-07-14
clinicaltrials.gov
Registry last updated
2026-09-29
clinicaltrials.gov
Primary completion date
2029-08-18
clinicaltrials.gov
Start date
2026-09-24
clinicaltrials.gov

Participants
900
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
900
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
25
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Akeso
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07700979
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07700979
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Overall survival (OS)

    Timeframe: Approximately up to 14months

    Time from randomization to death from any cause

  1. Progression-free survival(PFS)

    Timeframe: Approximately up to 8 months

    Time from the date of randomization to the date of progressive disease or death from any cause, whichever occurs first.

  2. Objective response rate (ORR)

    Timeframe: Approximately up to 8 months

  3. Disease control rate (DCR)

    Timeframe: Approximately up to 8 months

  4. Duration of response (DoR)

    Timeframe: Approximately up to 8 months

  5. Safety assessment

    Timeframe: Approximately up to 18 months

    Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. Able to provide written informed consent and can understand and comply with the requirements of the study.
  2. Histopathologically-confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma.
  3. No prior systemic therapy for locally advanced unresectable or metastatic G/GEJ adenocarcinoma. NOTE: For participants who have received prior neoadjuvant/adjuvant therapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
  4. ECOG PS of 0 or 1 within 3 days prior to randomization.
  5. Age ≥ 18 years at the time of voluntarily signing informed consent.
  6. Evaluable PD-L1 expression results.
  7. Participants must have at least one measurable lesion per RECIST v1.1 as assessed by investigator assessment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  8. Adequate organ function as indicated by the following laboratory values. Specimens must be collected within 7 days prior to the first dose of study treatment.
  9. Life expectancy ≥3 months.
  10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during treatment, and for at least 150 days after the last dose of cadonilimab/nivolumab, 270 days after the last dose of oxaliplatin, and 180 days after the last dose of capecitabine.
  11. Non-sterile males must agree to use effective contraception during treatment and for at least 120 days following the last dose of cadonilimab/nivolumab/capecitabine and 180 days after the last dose of oxaliplatin.

  1. Histopathologically confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma.
  2. Known HER2 positive. Be HER2-positive defined as either IHC 3+ or IHC 2+ in combination with ISH+ (or FISH).
  3. Participants with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  4. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1 time/month).
  5. Clinically significant bleeding symptoms within 28 days before the first dose or a definite tendency to bleed.
  6. Have a history of ≥ Grade 2 gastrointestinal perforation and/or fistulae (including prior gastric fistula operation) within 6 months prior to randomization.
  7. Participants who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
Sources for eligibility
clinicaltrials.gov

  • Mayo ClinicPhoenix, United StatesNot yet recruiting
  • UCLA HealthLos Angeles, United StatesNot yet recruiting
  • Rocky Mountain Cancer CentersDenver, United StatesNot yet recruiting
  • Yale School of MedicineNew Haven, United StatesNot yet recruiting
  • Dana Farber Cancer InstituteBoston, United StatesNot yet recruiting
  • Henry Ford HealthDetroit, United StatesNot yet recruiting
  • Mount SinaiNew York, United StatesNot yet recruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesNot yet recruiting
  • Oregon Health and Science UniversityPortland, United StatesNot yet recruiting
  • Sarah Cannon Research Institute (SCRI) - Oncology PartnersNashville, United StatesNot yet recruiting
  • Baylor Scott & White HealthDallas, United StatesNot yet recruiting
  • MD Anderson Cancer CenterHouston, United StatesNot yet recruiting
  • University of Wisconsin Carbone Cancer CenterMadison, United StatesNot yet recruiting
  • Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaNot yet recruiting
  • Peking University Cancer Hospital, Gastrointestinal Cancer Center IBeijing, ChinaRecruiting
  • Peking University Cancer Hospital, Gastrointestinal OncologyBeijing, ChinaNot yet recruiting
  • Guangdong Provincial People's HospitalGuangzhou, ChinaNot yet recruiting
  • Zhongshan Hospital Fudan UniversityShanghai, ChinaNot yet recruiting
  • Universitaetsklinikum EssenEssen, GermanyNot yet recruiting
  • University Cancer Center FrankfurtFrankfurt, GermanyNot yet recruiting
  • Universitätsmedizin der Johannes Gutenberg-UniversitätMainz, GermanyNot yet recruiting
  • Univerity MarburgMarburg, GermanyNot yet recruiting
  • Pratia MCM KrakówKrakow, PolandNot yet recruiting
  • Pratia PoznańPoznan, PolandNot yet recruiting
  • Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w WarszawieWarsaw, PolandNot yet recruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (1)

Targets (3)