Osimertinib monotherapy [OSI5]

For treating EGFR mutation positive unresectable locally advanced non-small- cell lung cancer after platinum-based chemoradiotherapy 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 documented non-small cell lung cancer (NSCLC) which is unresectable, locally advanced, stage 3 disease.
3. The patient’s NSCLC has been documented as exhibiting either an epidermal growth factor (EGFR) exon 19 deletion (Ex19del) or an exon 21 (L858R) substitution mutation, whether alone or in combination with other EGFR mutations Please mark below which type of mutation applies to this patient:

• exon 19 deletion (EX19del) or
• exon 21 (L858R) substitution mutation

4. The patient has not received any prior systemic treatment for this lung cancer diagnosis, other than the definitive chemoradiation as described in criterion 5.
5. The patient has received definitive chemoradiation, which can be given concurrently or sequentially. As part of this treatment, the patient must have received TWO or more cycles of platinum-based chemotherapy.
6. The patient’s lung cancer has not progressed during or after platinum-based chemoradiotherapy.
7. The patient will commence treatment with osimertinib no later than 6 weeks (42 days) after the last dose/fraction of chemotherapy/radiotherapy (whichever is the latter).
8. The patient has had no prior treatment with an EGFR inhibitor.
9. The patient has an ECOG performance status (PS) of 0 or 1.
10. The patient will be treated with osimertinib until whichever of the following events occur: disease progression or unacceptable toxicity or withdrawal of patient consent.
11. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, which MUST be approved before treatment is recommenced.
12. Osimertinib will be used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 07 May 2026

Additional information

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The data on this page was produced using version 1.397 of the CDF list, downloaded from NHS England’s website on 15 May 2026 at 18:00.

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