Cemiplimab with platinum-based chemotherapy [CEM2]

For untreated advanced non-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 cemiplimab in combination with platinum-based combination chemotherapy 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-confirmed diagnosis of non-small cell lung cancer (NSCLC) which is metastatic or locally advanced but not suitable for definitive chemoradiation and would be a candidate for pembrolizumab with platinum-based chemotherapy Please indicate whether squamous or non-squamous histology

• Squamous lung cancinoma
• Non-squamous lung carcinoma

3. The patient has stage IIIB or IIIC or IV NSCLC or has disease that has recurred more than 6 months after potentially curative treatment with local management of NSCLC with surgery/chemoradiotherapy/radiotherapy.
4. EGFR, ROS1 and ALK aberration testing have been done and all are negative.
5. PD-L1 testing with an approved and validated test and the tumour is scored as PD-L1 positive in 1% or more of the tumour cells.
6. The patient has not received prior treatment with an anti PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTL-4) antibody unless the patient completed or discontinued checkpoint inhibitor immunotherapy as part of adjuvant/neoadjuvant/maintenance therapy without disease progression on treatment and at least 6 months elapsed between the date of last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease.

Note

Note: NHS England does not commission any re-treatment with checkpoint inhibitor therapy for patients who have discontinued or completed previous checkpoint inhibitor therapy for the locally advanced/metastatic indication. Please mark below if the patient has received previous checkpoint inhibitor therapy and in which setting: - the patient has never received any immunotherapy for NSCLC. If so, please type ‘n/a’ in the ‘Time gap’ box below or - the patient has previously been treated with adjuvant immunotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous adjuvant immunotherapy and first diagnosis of disease relapse or - the patient has previously been treated with neoadjuvant treatment containing immunotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous neoadjuvant immunotherapy and first diagnosis of disease relapse or - the patient has previously been treated with maintenance immunotherapy post chemoradiotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous maintenance immunotherapy and first diagnosis of disease relapse Time gap in months after completion of previous adjuvant or neoadjuvant or maintenance checkpoint inhibitor immunotherapy and first diagnosis of disease relapse: _________ Note: the mandatory interval between the last date of administration of any prior adjuvant/neoadjuvant/maintenance immunotherapy and the date of first relapse is at least 6 months.

7. The patient will be treated with a maximum of 4 cycles of 3-weekly cemiplimab at a dose of 350mg plus platinum-based combination chemotherapy.
8. On completion of 4 cycles of cemiplimab plus platinum-based chemotherapy and in the absence of disease progression, treatment with cemiplimab will continue for a total treatment duration of 2 years* or until disease progression or unacceptable toxicity or withdrawal of patient consent, whichever occurs first. In patients with non-squamous histology who received a platinum/pemetrexed regimen maintenance pemetrexed will also be given *2 years treatment is defined as a maximum of 36 x 3-weekly cycles.
9. The patient has a performance status (PS) of 0 or 1.
10. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
11. Where a treatment break of more than 12 weeks beyond the expected cycle length is needed, a treatment break form will be completed to restart treatment, which MUST be approved, before treatment is re-commenced.
12. Cemiplimab will be otherwise used as set out in its Summary of Product Characteristics

CDF funded From: 26 May 2026

Additional information

Form version: -

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.400 of the CDF list, downloaded from NHS England’s website on 26 May 2026 at 14:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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