Published

May 11, 2025

Nivolumab [NIV5]

Nivolumab monotherapy for the treatment of SQUAMOUS locally advanced or metastatic non-small cell lung cancer after chemotherapy where the following criteria have been met:

  1. An application has been made by and the first cycle of systemic anti -cancer therapy 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 toxicities.
  3. The patient has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC).
  4. The patient has stage IIIB or IIIC or IV NSCLC or disease that recurred after previous potentially curative local management of NSCLC with surgery/chemoradiotherapy/radiotherapy.
  5. PD-L1 testing with an approved and validated test to determine the Tumour Proportion Score (TPS) has been attempted prior to this application and the result is set out below. Please document the actual TPS below (if negative, record ’0’) or enter ‘n/a’ if the TPS cannot be documented and the reason why below: TPS_____ If n/a, please indicate below the reason why the actual TPS cannot be documented:
  • the TPS result was unquantifiable OR
  • PD-L1 testing was not possible as the pathologist has documented that there is insufficient tissue for PD-L1 analysis
  1. The patient has progressed either after treatment with at least two cycles of platinum-based doublet chemotherapy for stage IIIB or IIIC or IV or recurrent NSCLC after previous potentially curative local management or has progressed within 6 months of completing platinum-based adjuvant or neoadjuvant therapy or chemoradiation and if appropriate that the patient has had all appropriate targeted treatments if the patient has a tumour which is positive for an actionable genomic change in relation to EGFR or ALK or ROS1 or MET exon 14 or KRAS G12C or RET or BRAF V600 status.
  2. 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 discontinued or completed checkpoint inhibitor immunotherapy as part of adjuvant/neoadjuvant/maintenance therapy without disease progression and at least 6 months elapsed between the date of the last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease. Note: NHS England does not commission 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 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 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 immunotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of 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 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. For patients suffering a first relapse within 6-12 months of previous immunotherapy, clinicians should bear in mind the long elimination half-lives of immunotherapies and make individual assessments of the overall benefit/risk ratio of re-treatment with immunotherapy.
  1. Treatment with nivolumab will continue for a total of 2 years* or until disease progression or unacceptable toxicity or withdrawal of patient consent, whichever occurs first. *2 years treatment is defined as a maximum of 52 x 2-weekly nivolumab administrations or 26 x 4-weekly administrations.
  2. Nivolumab will be administered as monotherapy at a dose of 240mg every 2 weeks or 480mg every 4 weeks. Note: nivolumab 480mg every 4 weeks is unlicensed, therefore Trust policy regarding the use of unlicensed treatments must be followed if using this dosing schedule.
  3. The patient has an ECOG performance status of 0 or 1.
  4. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  5. A formal review as to whether treatment with nivolumab should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  6. When a treatment break of more than 12 weeks beyond the expected 2 or 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including as appropriate if the patient had an extended break on account of Covid-19.
  7. Nivolumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 19 January 2021

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA655 (21 October 2020)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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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