Osimertinib in combination with pemetrexed and platinum- based chemotherapy [OSI4]

Osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first line treatment of adult patients with recurrent or locally advanced or metastatic non-small cell lung cancer exhibiting epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with osimertinib plus pemetrexed and platinum-based chemotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a histologically or cytologically documented non-small cell lung cancer (NSCLC) that has been shown to exhibit an epidermal growth factor (EGFR) exon 19 deletion exon 21 (L858R) substitution mutation OR there is documented agreement by the lung MDT that the radiological appearances are in keeping with recurrent/locally advanced/metastatic NSCLC AND there is an informative circulating free DNA test result confirming the presence of an exon 19 deletion or exon 21 (L858R) substitution mutation. Please mark below on which basis the exon 19 deletion or exon 21 substitution mutation positive NSCLC has been made in this patient:

• histological or cytological evidence and tissue/ctDNA testing or
• there is documented agreement by the lung MDT that the radiological appearances are in keeping with recurrent/locally advanced/metastatic NSCLC AND there is an informative circulating free DNA test result confirming the presence of an exon 19 deletion or exon 21 (L858R) substitution mutation.

3. The patient has recurrent or locally advanced or metastatic disease.
4. For the recurrent/locally advanced/metastatic disease indication, the patient has not received any previous cytotoxic chemotherapy or immunotherapy unless there was a clinically urgent need to give cytotoxic chemotherapy before the EGFR mutation status was known, in which case the patient may have received one cycle of cytotoxic chemotherapy. Please mark below which scenario applies to this patient:

• no prior treatment with cytotoxic chemotherapy or immunotherapy for the recurrent/locally advanced/metastatic indication
• a single cycle of cytotoxic chemotherapy was given due to a clinically urgent need to start treatment before the status of the EGFR mutation was known

5. The patient has had no prior treatment with an EGFR inhibitor unless osimertinib has been received as adjuvant treatment for resected stages IB to N2 only IIIB NSCLC with either EGFR exon 19 deletion or exon 21 substitution mutation and the patient did not progress whilst still receiving adjuvant osimertinib. Please mark below which scenario applies to this patient:

• no prior treatment with an EGFR inhibitor
• previously received adjuvant osimertinib for resected stages IB to N2 only IIIB NSCLC and did not progress whilst still receiving adjuvant osimertinib Please state in the box below how many months have elapsed since discontinuation of adjuvant osimertinib (or enter ‘n/a’ if not applicable): ________________

6. Osimertinib will be given in combination with a maximum of 4 cycles of a pemetrexed and platinum-based chemotherapy regimen and then with maintenance pemetrexed monotherapy as appropriate. Note: it is expected that the platinum choice will be either carboplatin (AUC5 mg/ml/min) or cisplatin (75mg/m²).
7. Osimertinib will be commenced at the recommended maximum dose of 80 mg once daily. Note: the use of osimertinib doses higher than 80mg per day are not commissioned.
8. The patient has known CNS spread or not and that if CNS spread is present the patient is either asymptomatic and not requiring regular steroids or has a stable neurological status for at least 2 weeks after completion of definitive therapy. Please mark below which scenario applies to this patient:

• no known CNS metastases or
• CNS spread has been documented and the patient is either asymptomatic and not requiring regular steroids or has a stable neurological status for at least 2 weeks after completion definitive therapy

9. The patient has an ECOG performance status (PS) of 0 or 1.
10. The patient will be treated with osimertinib until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner. Note: the use of osimertinib should be stopped if there is disease progression in the CNS that cannot be treated with surgery or stereotactic radiotherapy.
11. A formal medical review as to how osimertinib plus chemotherapy is being tolerated and whether treatment with such treatment should continue or not will be scheduled to occur at least by the end of the second 3-weekly cycle of treatment.
12. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
13. Osimertinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 10 April 2025 - anticipated to move to NHS funding: 27 May 2025

Additional information

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The data on this page was produced using version 1.358 of the CDF list, downloaded from an archive of NHS England’s website on 10 April 2025 at 14:00.

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