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.
Other
Pharmacovigilence
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.
Amendments
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.
Guidelines
- Paper CRF Completion Guidelines [pdf, 304 KB]
- SAE Form Completion Guidelines [pdf, 148 KB]
- Electronic Remote Data Capture (eRDC) User Manual [pdf, 1,875 KB]
- Screening Registration Process [pdf, 301 KB]
- Instructions for use of Carbon Monoxide Monitors [pdf, 583 KB]
- MicroCO-Meter Operating Manual [pdf, 1,364 KB]
- Cenduit Site User Guide [pdf, 713 KB]
- Laboratory Manual v8.0 23-Apr-2021 [pdf, 559 KB]
Pharmacy Documents
Site specific Pfizer IMP Order Forms are available from the National Lung Matrix Trial Office.
- Arm A AZD4547 Example Pharmacy Prescription Form [pdf, 138 KB]
- Arm B Vistusertib Example Pharmacy Prescription Form [pdf, 138 KB]
- Arm C Palbociclib Example Pharmacy Prescription Form [pdf, 136 KB]
- Arm D Crizotinib Example Pharmacy Prescription Form [pdf, 136 KB]
- Arm E Selumetinib Example Pharmacy Prescription Form [pdf, 137 KB]
- Arm E Docetaxel Example Pharmacy Prescription Form [pdf, 135 KB]
- Arm F AZD5363 Example Pharmacy Prescription Form [pdf, 53 KB]
- Arm G AZD9291 Example Pharmacy Prescription Form [pdf, 138 KB]
- Arm H Sitravatinib Example Pharmacy Prescription Form [pdf, 137 KB]
- Arm NA Cohort NA1 MEDI4736 Example Pharmacy Prescription Form [pdf, 53 KB]
- Arm J AZD6738 Example Pharmacy Prescription Form [pdf, 54 KB]
- Arm J Durvalumab Example Pharmacy Prescription Form [pdf, 54 KB]
- Temperature Deviation Form [pdf, 65 KB]
- Palbociclib IMP Trial Label [pdf, 84 KB]
- Docetaxel IMP Trial Label [pdf, 97 KB]
- Crizotinib IMP Trial Label [pdf, 253 KB]