Nivolumab plus chemotherapy [NIV23]

For the neoadjuvant treatment of 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 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 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 documented diagnosis of non-small cell lung cancer (NSCLC). Please mark below which histology applies to this patient:
  • squamous NSCLC
  • non-squamous NSCLC
  1. The patient either 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.
  1. 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) Note: the trial included patients staged using the UICC/AJCC TNM 7th edition and hence the marketing authorisation uses the 7th edition staging system. As NSCLC clinical staging is now reported using the UICC/AJCC TNM 8th edition, the corresponding 7th edition stages included in the marketing authorisation have been translated into those of the 8th edition. are
  1. The patient has been staged as having M0 disease.
  2. The patient has been assessed by the thoracic surgical team to be eligible for a potentially curative resection and that the patient has the necessary fitness to undergo such surgery.
  3. The patient will be treated with a maximum of 3 cycles of neoadjuvant therapy with the combination of nivolumab 360mg and platinum-based chemotherapy, each cycle planned to be given every 3 weeks.
  4. 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: the partner cytotoxic drugs to cisplatin/carboplatin can be pemetrexed or paclitaxel or gemcitabine or vinorelbine.
  1. The intent is for the patient to potentially undergo resection within 6 weeks of completing the final 3-week cycle of neoadjuvant nivolumab plus chemotherapy.
  2. 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.
  3. The patient has an ECOG performance status (PS) of 0 or 1.
  4. Nivolumab will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent or on completion of 3 cycles of treatment with nivolumab.
  5. A formal medical review as to how nivolumab plus chemotherapy is being tolerated and whether treatment with nivolumab plus chemotherapy should be completed or not will be scheduled to occur at least by the end of the second cycle of treatment.
  6. When a treatment break of more than 3 months beyond the expected 3-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, including indicating as appropriate if the patient had an extended break because of Covid-19.
  7. The prescribing clinician is aware of the following issues which relate to the subsequent management of this patient following neoadjuvant nivolumab plus chemotherapy:
  8. Nivolumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 20 June 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA876 (22 March 2023)

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The data on this page was produced using version 1.336 of the CDF list, downloaded from an archive of NHS England’s website on 11 January 2025 at 21:05.

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