Trial documents

Links to the current Protocol, Patient Information Sheets and Informed Consent Forms and all other patient documents are provided below. If there has been a recent amendment to the trial please ensure that you have obtained R&D approval before using the updated versions of these documents. 

All other documents distributed by the National Lung Matrix Trial Office should also be available for download. Please contact the Trial Office if you cannot find the document you are looking for, or if you require username and password login access.

Change of Staff

If there are any changes to the staff working on this trial, please complete the relevant staff Registration Form below. Please also ensure that the Site Signature and Delegation Log (SS&DL) is updated and return both documents to the National Lung Matrix Trial Office, from which site specific versions of the SS&DL are also available. 

Trial Documents

Trial Protocol and supplementary documents

Patient Documents

Patient Information Sheets & Informed Consent Forms

Please note: all PIS & ICFs should be localised using hospital headed paper.

Any PIS & ICF Addendums developed for re-consenting patients after a specific substantial amendment are available below - please click on the separate page relevant for the amendment.

GP Letters

Please note: all GP Letters should be localised using hospital headed paper.

Patient Diaries

To print in A5 booklet format, in printing settings select 'booklet' and change orientation to Landscape.



Investigator's Brochures (IBs) and Summaries of Product Characteristics (SPCs)

The latest Summary of Product Characteristics provided to the National Lung Matrix Trial Office is available below. Please ensure the latest versions are available in both the Investigator Site File and Pharmacy File. Whilst all the latest Investigator’s Brochures and Summary of Product Characteristics are provided to sites immediately for their reference, these will be submitted yearly to the MHRA by substantial amendment on the DSUR deadline in December.

Please contact the Trial Office if you require copies of the latest Investigator's Brochures.

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on the Investigator Site File or Pharmacy File Version Control Lists.

Links to these and other Version Control Lists used in this trial are below.


Below are links to all of the substantial amendments made to this trial. The folders contain all of the relevant amended documentation and approval letters.  Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

Please note: the above combined documents will not be updated any further. Please see the links below for approval documentation for each separate amendment.

Data Collection

Sample Collection

Site specific versions of ctDNA (whole blood/plasma), PBMC and Tumour (molecular testing/optional research) Sample Collection Forms, Biocair Starter Packs (includes shipment request form), and further supplies of Laboratory Consumables and Sample Labels are available from the National Lung Matrix Trial Office.


Pharmacy Documents

Site specific Pfizer IMP Order Forms are available from the National Lung Matrix Trial Office.

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