Dabrafenib in combination with trametinib [DABTRA3]

For the first line treatment of metastatic BRAF V600 mutation positive non-small cell lung cancer where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with dabrafenib in combination with trametinib 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 confirmed diagnosis of non-small cell lung cancer (NSCLC).
  3. The patient has histological or cytological evidence of NSCLC that contains a BRAF V600E mutation based on a validated test OR there is documented agreement by the lung MDT that the radiological appearances are in keeping with metastatic NSCLC AND there is an informative circulating free DNA test result confirming the presence of a BRAF V600E mutation. Please mark below on which basis the diagnosis of BRAF V600E mutation positive NSCLC has been made in this patient:
  • Histological or cytological evidence or
  • Documented agreement by the lung MDT that the radiological appearances are in keeping with metastatic NSCLC and there is an informative circulating free DNA test result confirming the presence of a BRAF V600E mutation
  1. The patient has metastatic non-small cell lung cancer.
  2. I confirm that the patient is treatment naïve to BRAF and MEK inhibitors for the treatment of metastatic NSCLC.
  3. I confirm that the patient has not received any previous systemic therapy for metastatic NSCLC. Note: any prior adjuvant or neoadjuvant chemotherapy or immunotherapy for NSCLC does not count as previous systemic therapy in this regard.
  4. The patient has an ECOG performance status of either 0 or 1 or 2. Please enter below as to which ECOG performance status applies to this patient:
  • ECOG PS 0 or
  • ECOG PS 1 or
  • ECOG PS 2
  1. The patient either has no known brain metastases or if the patient has brain metastases, the patient is symptomatically stable prior to starting dabrafenib in combination with trametinib.
  2. Treatment with dabrafenib in combination with trametinib will be continued until loss of clinical benefit or unacceptable toxicity or withdrawal of patient consent.
  3. A formal medical review as to how the combination of dabrafenib and trametinib is being tolerated and whether treatment with the combination of dabrafenib and trametinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  4. Where a treatment break of more than 6 weeks beyond the expected cycle length is needed, a treatment break approval form will be completed to restart treatment.
  5. Dabrafenib in combination with trametinib is to be otherwise used as set out in their respective Summaries of Product Characteristics.

[NHS funded]{.badge .rounded-pill .bg-success} From: 12 September 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA898 (14 June 2023)

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