Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Required: HER2 (ERBB2) overexpression or amplification negativity (IHC 0/1+, or IHC 2+ with FISH/ISH negative) (IHC 0/1+, or IHC 2+ with FISH/ISH negative)

Provide a report confirming HER2 overexpression or amplification negativity; defined as IHC 0/1+, or IHC 2+ with FISH/ISH negative.

Cannot have received: systemic therapy

Exception: adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy, or chemoradiotherapy) for GC/GEJC allowed if time to first recurrence or progression > 6 months from end of last treatment; prior anti-tumor Traditional Chinese Medicine preparations allowed if discontinued ≥ 2 weeks before enrollment

No prior systemic therapy for advanced or metastatic GC/GEJC (including anti-HER-2 therapy). Patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy, or chemoradiotherapy) for GC/GEJC are eligible if the time to first recurrence or disease progression is greater than 6 months from the end of the last treatment. Prior use of anti-tumor Traditional Chinese Medicine preparations is allowed but must be discontinued at least 2 weeks before enrollment.

Cannot have received: anti-PD-1 therapy

Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.

Cannot have received: anti-PD-L1 therapy

Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.

Cannot have received: anti-CTLA-4 therapy

Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.