Published

May 11, 2025

Pembrolizumab [PEMB8]

Pembrolizumab in combination with pemetrexed- and platinum-based chemotherapy for the first line treatment of PD-L1 positive or negative locally advanced or metastatic non-squamous non-small cell lung cancer where all the following criteria are met:

  1. This application has been made by and the first cycle of systemic anti-cancer therapy with pembrolizumab in combination with pemetrexed- and platinum-based combination 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 toxicities.
  3. The patient has a histologically- or cytologically-confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
  4. The patient has stage IIIB or IIIC or IV NSCLC or has disease that has recurred after potentially curative treatment with local management of NSCLC with surgery/chemoradiotherapy/radiotherapy.
  5. EGFR and ALK mutation testing have been done and both are negative.
  6. 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. Note: for fully informed patient consent of all the potential 1st line treatment options, PD-L1 testing must still be attempted and recorded here. Please document the actual TPS below (if negative, record ’0’) or enter ‘n/a’ if the TPS cannot be documented and the reason why: 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. Either the patient has not received any previous systemic therapy for NSCLC or the patient completed the last treatment with chemotherapy or chemoradiotherapy or checkpoint inhibitor immunotherapy as part of adjuvant/neoadjuvant/maintenance therapy at least 6 months prior to the first diagnosis of locally recurrent or metastatic disease. Please indicate below whether the patient has received any previous adjuvant or neoadjuvant or maintenance systemic therapy for NSCLC:
  • the patient has not been previously treated with any adjuvant or neoadjuvant or maintenance systemic therapy for NSCLC or
  • the patient has been previously treated with adjuvant systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic disease or
  • the patient has been previously treated with neoadjuvant systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic disease or
  • the patient has been previously treated with maintenance systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic disease
  1. 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: 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. 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 an individual assessment of the overall benefit/risk ratio of re-treatment with immunotherapy.
  1. The patient will be treated with a maximum of 4 cycles of pembrolizumab plus pemetrexed- and platinum-based combination chemotherapy with either cisplatin or carboplatin (AUC 5). Please indicate below whether the pemetrexed will be given in combination with:
  • cisplatin OR
  • carboplatin (AUC 5)
  1. On completion of 4 cycles of pembrolizumab plus pemetrexed with carboplatin or cisplatin based chemotherapy, pembrolizumab will be administered as 3-weekly or 6-weekly cycles or pembrolizumab will be administered according to the extended dosing schedule to which the patient has been randomised as per the protocol in the NIHR-approved REFINE-Lung trial (Reference NIHR133011).
  2. On completion of 4 cycles of pembrolizumab plus pemetrexed-based chemotherapy in combination with cisplatin or carboplatin and in the absence of disease progression, treatment with pembrolizumab 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. *2 years treatment is defined as a maximum of 35 x 3-weekly cycles or the equivalent numbers of cycles if either 6-weekly dosing is used or is defined by the extended dosing schedule to which the patient has been randomised as per the protocol in the NIHR-approved REFINE-Lung trial (Reference NIHR133011).
  3. The patient has a performance status (PS) of 0 or 1 and is fit for pemetrexed- and platinum-based chemotherapy in combination with pembrolizumab.
  4. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  5. A formal medical review as to whether treatment with pembrolizumab in combination with pemetrexed plus cisplatin/carboplatin should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  6. 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, including an indication as appropriate if the patient had an extended break because of COVID 19.
  7. Pembrolizumab will be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 08 June 2021

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA683 (10 March 2021)

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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