Nivolumab [NIV25]

Nivolumab plus chemotherapy for neoadjuvant treatment and then continued as adjuvant monotherapy in adults with previously untreated UICC/AJCC 8th edition stage IIA or IIB or IIIA or N2 only IIIB non- small cell lung cancer AND who are candidates for potentially curative surgery where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with neoadjuvant nivolumab in combination with 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 documented diagnosis of non-small cell lung cancer (NSCLC). Please mark below which histology applies to this patient:

• squamous NSCLC
• non-squamous NSCLC

3. Either the patient has been documented as NOT having a NSCLC which harbours an EGFR 19 or 21 mutation or an ALK gene fusion or the patient has a squamous cell carcinoma and a decision to not test for an EGFR 19 or 21 mutation or an ALK gene fusion and proceed with nivolumab has been made following discussion at the Lung Cancer MDT and consideration of the relevant patient characteristics (including age and smoking status). Please mark below which option applies to this patient:

• Documented as NOT having a NSCLC which harbours an EGFR 19 or 21 mutation or an ALK gene fusion
• Patient has squamous NSCLC and a decision to not test for an EGFR 19 or 21 mutation or an ALK gene fusion and proceed with nivolumab has been made following discussion at the Lung Cancer MDT

4. The clinical TNM staging has been agreed at the appropriate Lung Cancer MDT meeting to be stage IIA or IIB or IIIA or N2 only IIIB tumour according to the UICC/AJCC TNM 8th edition. Please mark below which stage applies to this patient:

• stage IIA disease (T2b N0)
• stage IIB disease (T1a N1 or T1b N1 or T1c N1 or T2a N1 or T2b N1 or T3 N0)
• stage IIIA disease (T1a N2 or T1b N2 or T1c N2 or T2a N2 or T2b N2 or T3 N1 or T4 N0 or T4 N1)
• N2 only stage IIIB disease (T3 N2 or T4 N2)

5. The patient has been staged as having M0 disease and has been assessed by the thoracic surgical team to be eligible and fit for a potentially curative resection.
6. The intent is to treat the patient with a maximum of 4 cycles of 3-weekly neoadjuvant platinum-based chemotherapy in combination with 3 weekly intravenous nivolumab at a dose of 360mg.

Note

Note: Subcutaneous nivolumab at a dose of 900mg every three weeks is NOT commissioned by NHS England in the neoadjuvant phase, in this indication.

7. The chemotherapy partner to this neoadjuvant combination will be a 2-drug platinum-based combination with the platinum component being either cisplatin or carboplatin given at a dose of at least AUC of 5mg/ml/min. Please mark below which will be the platinum-based component of the 2-drug combination:

• cisplatin
• carboplatin given with a drug dose of at least AUC 5mg/ml/min

Note

Note: the partner cytotoxic drugs to cisplatin/carboplatin can be pemetrexed or paclitaxel or gemcitabine or vinorelbine.

8. The intent is for the patient to potentially undergo resection within 20 weeks of the 1st dose of neoadjuvant therapy.
9. The intent is for the patient to commence adjuvant nivolumab monotherapy no later than 12 weeks after surgery, with nivolumab administered at a dose of 1200mg every 4 weeks given by subcutaneous injection. Adjuvant nivolumab monotherapy can be given for a maximum of 13 x 4 weekly cycles, and then it MUST be discontinued.
10. The intent for any patient requiring any form of post-operative radiotherapy is for this to start no later than 8 weeks after surgery and for adjuvant nivolumab to commence no later than 4 weeks after completion of radiotherapy.
11. The patient has not received any previous anticancer therapy for this NSCLC or any prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4) antibody.
12. The patient has an ECOG performance status (PS) of 0 or 1.
13. Nivolumab will be stopped at whichever of the following events occurs first: any local or distant disease progression at any time in the neoadjuvant, peri-operative and adjuvant phases of treatment or unacceptable toxicity or withdrawal of patient consent or on completion of the maximum allowed duration of treatment with adjuvant nivolumab as outlined above.
14. When a treatment break of more than 12 weeks beyond the expected 3-weekly or 4-weekly cycle length (as appropriate) is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, which MUST be approved before treatment is recommenced.
15. The prescribing clinician is aware of the following issues which relate to the subsequent management of this patient following neoadjuvant nivolumab plus chemotherapy: i) if the patient has a resection, then post-operative radiotherapy or chemoradiotherapy can be given if indicated and in the absence of any progressive disease, the patient can proceed to adjuvant nivolumab ii) if the patient does not have a resection, then radiotherapy or chemoradiotherapy can be given if indicated and in the absence of any progressive disease, the patient can proceed to adjuvant nivolumab iii) if the patient does not have surgery or radiotherapy or chemoradiotherapy, no adjuvant nivolumab can be given iv) if there is disease progression during neoadjuvant or adjuvant nivolumab, no further anti-PD1 oranti-PDL1 immunotherapy is funded in any indication
16. Nivolumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 20 January 2025

Additional information

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The data on this page was produced using version 1.385 of the CDF list, downloaded from NHS England’s website on 27 January 2026 at 22:25.

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