Durvalumab with chemotherapy [DUR9]

For neoadjuvant and adjuvant treatment then alone for adjuvant treatment of resectable gastric or gastro-oesophageal junction adenocarcinoma where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy will be prescribed by a consultant, or internally accredited oncology specialty trainee, specifically trained and assessed in the use of systemic anti-cancer therapy.
2. The patient has a histologically or cytologically determined diagnosis of resectable gastric or gastro‑oesophageal junction (GEJ) adenocarcinoma, and the intent is to treat the patient with radical surgery following systemic neo-adjuvant treatment.
3. The patient has disease which is stage II–III or IVA and is deemed as resectable.
4. The patient has not received any prior chemotherapy or immunotherapy (including anti–CTLA‑4, anti–PD‑1, anti–PD‑L1, or anti–PD‑L2 antibodies) for the treatment of gastric or gastro-oesophageal junction cancer.
5. In the neo-adjuvant phase, durvalumab will be given alongside FLOT chemotherapy, at a dose of 1,500mg every FOUR weeks, for up to TWO cycles prior to surgery.
6. Treatment with adjuvant durvalumab monotherapy will be given at a dose of 1,500mg every FOUR weeks as below • For up to TWO cycles in combination with FLOT chemotherapy, followed by • Up to TEN cycles as monotherapy.
7. Treatment with adjuvant durvalumab will continue until disease progression or unacceptable toxicity or withdrawal of patient consent or for a maximum total of TWELVE doses post- surgery (this total includes any adjuvant doses of durvalumab given alongside FLOT chemotherapy), whichever occurs first.
8. The patient has a current ECOG performance status of 0 or 1.
9. When a treatment break of more than 12 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment. This must be approved before durvalumab is re-commenced.
10. Durvalumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 14 May 2026

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