Published

February 19, 2025

Pembrolizumab in combination with chemotherapy [PEMB30]

Pembrolizumab in combination with chemotherapy for neoadjuvant treatment and then continued as adjuvant monotherapy in adults with previously untreated UICC/AJCC 8th edition stage 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 pembrolizumab 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).
  4. 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 pembrolizumab 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 pembrolizumab 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)
  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 has not received any systemic therapy of any kind for the treatment of NSCLC.
  4. The intent is to treat the patient with a maximum of 4 cycles of 3-weekly neoadjuvant platinum-based chemotherapy in combination with 3- or 6-weekly pembrolizumab.
  5. 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: IIA
  • 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 20 weeks of the 1st dose of neoadjuvant therapy.
  2. The intent is for the patient to commence adjuvant pembrolizumab monotherapy no later than 12 weeks after surgery for a maximum of either 13 x 200mg 3-weekly pembrolizumab doses or 7 x 400mg 6-weekly pembrolizumab doses and then discontinue treatment with pembrolizumab.
  3. 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 pembrolizumab to commence no later than 4 weeks after completion of radiotherapy.
  4. 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.
  5. The patient has an ECOG performance status (PS) of 0 or 1.
  6. Pembrolizumab 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 pembrolizumab as outlined above.
  7. A formal medical review as to how pembrolizumab plus chemotherapy is being tolerated and whether treatment with pembrolizumab plus chemotherapy should be completed or not will be scheduled to occur at least by the end of the second cycle of treatment.
  8. When a treatment break of more than 3 months beyond the expected 3-weekly or 6-weekly cycle length (as appropriate) is needed, I will complete a treatment break approval form to restart treatment.
  9. The prescribing clinician is aware of the following issues which relate to the subsequent management of this patient following neoadjuvant pembrolizumab 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 pembrolizumab ii) 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 pembrolizumab iii) if the patient does not have surgery or radiotherapy or chemoradiotherapy, no adjuvant pembrolizumab can be given iv) if there is disease progression during neoadjuvant or adjuvant pembrolizumab, no further anti-PD1 or anti-PDL1 immunotherapy is funded in any indication
  10. Pembrolizumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 19 February 2025

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA1017 (20 November 2025)

Current Form Version

Note

The data on this page was produced using version 1.348 of the CDF list, downloaded from an archive of NHS England’s website on 19 February 2025 at 18:00.

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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