Durvalumab in combination with etoposide plus either carboplatin or cisplatin [DUR4]

For the first-line treatment of adult patients with extensive-stage small cell lung cancer where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with durvalumab in combination with etoposide plus carboplatin or cisplatin will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
3. The patient has a histologically or cytologically determined diagnosis of small cell lung cancer (SCLC).
4. The patient has been staged as having extensive stage small cell lung cancer (SCLC).
5. The patient has not received previous systemic therapy for his/her extensive stage SCLC. Previous treatment with concurrent chemoradiotherapy for limited stage SCLC is allowed as long as therapy was completed at least 6 months prior to the diagnosis of recurrent and extensive stage disease.
6. The patient has an ECOG performance status score of 0 or 1.
7. The patient will be treated with a maximum of four 3-weekly cycles of durvalumab in combination with etoposide (80-100mg/m² IV on days 1-3 or its oral equivalent on days 2-3) plus either carboplatin (AUC 5 or 6 mg/ml/min) or cisplatin (75-80mg/m²).
8. On completion of durvalumab in combination with chemotherapy and in the absence of disease progression, treatment with durvalumab maintenance monotherapy will continue until disease progression or symptomatic deterioration or unacceptable toxicity or withdrawal of patient consent, whichever occurs first.
9. The dosing of atezolizumab will be at an intravenous dose of 1500mg given every 3 weeks in combination with chemotherapy and at a dose of 1500mg given every 4 weeks as monotherapy maintenance therapy.
10. As part of informed consent the patient has been given the options of receiving either durvalumab plus chemotherapy and then maintenance intravenous 4-weekly durvalumab or atezolizumab plus chemotherapy and then maintenance subcutaneous 3-weekly atezolizumab and has chosen the intravenous 4-weekly durvalumab option.
11. The patient has no symptomatically active brain metastases or leptomeningeal metastases
12. The patient has had no prior treatment with anti-PD-L1/PD-1 therapy for small cell lung cancer, unless this was received for this indication via a company early access program and all treatment criteria on this form are fulfilled.
13. A formal medical review as to how treatment with durvalumab in combination with etoposide plus carboplatin or cisplatin is being tolerated and whether treatment with durvalumab plus chemotherapy should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
14. Where a treatment break of more than 12 weeks beyond the expected 3- or 4-weekly cycle length is needed, I confirm that I will complete a treatment break approval form to restart treatment.
15. Durvalumab, etoposide and carboplatin or cisplatin will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

CDF funded From: 20 January 2025

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