Clinical Research Directory

Inclusion Criteria: * Signed screening informed consent * Age ≥ 18 years * Availability of a diagnostic tumour sample for central evaluation (FFPE block or minimum 10 slides). * Histologically proven, previously untreated, locally advanced, resectable gastric/GEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0. Note: if the results of the staging laparoscopy are pending at this stage it is acceptable to include the patients in this step, in the interest of patient time-to-treatment. * Planned peri-operative treatment with FLOT chemotherapy and surgically assessed feasible R0 resection * Centrally confirmed FGFR2b overexpression as defined by ≥10% tumour cells with 2+/3+ FGFR2b staining by immunohistochemistry (IHC) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Previously untreated, locally advanced, histologically confirmed, resectable gastric/GEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0 by radiological and surgical staging * Adequate hematologic and organ function Exclusion Criteria: * Prior anticancer treatment for the disease under investigation * History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmologic corticosteroids * Evidence of any ongoing ophthalmologic abnormalities or symptoms that are recent (within 4weeks) or actively progressing * Unwillingness to avoid the use of contact lenses during study treatment and follow-up period of at least 100 days after end of treatment. * Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmologic laser treatment * History of solid organ transplantation * History of interstitial lung disease * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study * Patients on immunosuppressive therapy or having immune system disorders, including auto-immune diseases. Concurrent steroid use of not more than an equivalent of 10 mg/day prednisolone is allowed. Inhaled, intranasal, intraocular, and/or joint injections of corticosteroids are allowed.