Amivantamab in combination with lazertinib [AMI1]

For the first line treatment of locally advanced or metastatic non-small cell lung cancer in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with amivantamab with lazertinib 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 or cytologically documented non-small cell lung cancer (NSCLC) that has been shown to exhibit an epidermal growth factor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation OR there is documented agreement by the lung MDT that the radiological appearances are in keeping with recurrent/locally advanced/metastatic NSCLC AND there is an informative circulating free DNA test result confirming the presence of an exon 19 deletion or exon 21 (L858R) substitution mutation. Please mark below on which basis the diagnosis of EGFR mutation positive NSCLC has been made in this patient:

• Histological or cytological evidence and tissue/ctDNA testing, or
• Documented agreement by the lung MDT that the radiological appearances are in keeping with locally advanced or metastatic NSCLC and there is an informative circulating free DNA test result confirming the presence of an exon 19 deletion or exon 21 (L858R) substitution mutation.

3. The patient has locally advanced or metastatic disease, and that for this disease indication, the patient has not received any previous cytotoxic chemotherapy or immunotherapy.
4. The patient has had no prior treatment with an EGFR inhibitor unless osimertinib has had to be stopped within 6 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression, or osimertinib has been received as adjuvant treatment for resected stages IB to N2 only IIIB NSCLC with either an EGFR exon 19 deletion or exon 21 substitution mutation and the patient did not progress whilst still receiving adjuvant Osimertinib, or within 12 months of the last dose of osimertinib being taken. Please mark below which scenario applies to this patient:

• no prior treatment with an EGFR inhibitor
• previous treatment with Osimertinib (in the locally advanced or metastatic setting) but treatment has had to be stopped within 6 months of its start solely as a consequence of dose- limiting toxicity and in the clear absence of progressive disease
• previously received adjuvant osimertinib for resected stages IB to N2 only IIIB NSCLC, and did not progress whilst still receiving adjuvant Osimertinib, or within 12 months of the last dose of osimertinib being taken. Please state in box below how many months have elapsed since discontinuation of adjuvant osimertinib (or enter ‘n/a’ if not applicable):__________

5. The patient has an ECOG performance status (PS) of 0 or 1.
6. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner. If a patient experiences severe toxicity specifically related to amivantamab, lazertinib can be continued as a single agent

Note

Note: the use of amivantamab and lazertinib should be stopped if there is disease progression in the CNS that cannot be treated with surgery or stereotactic radiotherapy.

7. Where a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment is recommenced.
8. Amivantamab and lazertinib will be used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 18 December 2025

Additional information

Form version: -

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.380 of the CDF list, downloaded from NHS England’s website on 25 December 2025 at 11:00.

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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