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ASCO GI 2026 | LUCERNA: zolbetuximab, pembrolizumab, and chemotherapy in gastric cancer
Kohei Shitara, MD, National Cancer Center Hospital East, Kashiwa, Japan, comments on the Phase III LUCERNA trial (NCT06901531) of zolbetuximab with pembrolizumab and chemotherapy as first-line therapy for patients with locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The study targets tumors that are HER2-negative, CLDN18.2-positive, and PD-L1-positive. Patients are randomized to receive the triplet regimen or placebo with pembrolizumab and chemotherapy. The primary endpoint is overall survival. This interview took place at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco, CA.
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Transcript
LUCERNA is a phase 3 ongoing global study to test a combination with FOLFOX, zolbetuximab, and Pembrolizumab compared with FOLFOX plus Pembrolizumab as a standard care. The eligible patient should be a patient with high Claudin 2 expression, defined as 75% or more tumor cells with moderate to strong expression. And this is exactly the same criteria with currently approved indication for zolbetuximab...
LUCERNA is a phase 3 ongoing global study to test a combination with FOLFOX, zolbetuximab, and Pembrolizumab compared with FOLFOX plus Pembrolizumab as a standard care. The eligible patient should be a patient with high Claudin 2 expression, defined as 75% or more tumor cells with moderate to strong expression. And this is exactly the same criteria with currently approved indication for zolbetuximab. And this is based on previous illustrative data supporting high claudin expression is needed even with a combination with checkpoint inhibitor. We also require CPS 1 or higher. This is the current standard criteria to limit the use of checkpoint inhibitor. And this is also based on ILLUSTRO study, which showed a better outcome of PFS in patients with CPS 1 or higher as well as high claudin 18.2 expression. Since this is an international study, the enrollment is ongoing in multiple regions like Japan, China, and US or other EU countries, etc. The trial is still ongoing and hopefully it may change the clinical practice in the near future.
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