Trial Protocol and supplementary documents
- Trial Protocol [pdf, 5.03 MB]
- Protocol synopsis [pdf, 325 KB]
- Pharmacy Manual [pdf, 1,595 KB]
- Laboratory Manual [pdf, 404 KB]
- Prohibited & Concomitant Medications Document [pdf, 309 KB]
Patient Documents
Patient Information Sheets & Informed Consent Forms
- Arm A: AZD4547 PIS and ICF - arm now closed to recruitment
- Arm B: Vistusertib (AZD2014) PIS and ICF [doc, 265 KB]
- Arm C: Palbociclib PIS and ICF [doc, 244 KB]
- Arm D: Crizotinib PIS and ICF [doc, 254 KB]
- Arm E: Selumetinib & Docetaxel PIS and ICF [doc, 482 KB]
- Arm F: AZD5363 PIS and ICF - arm now closed to recruitment
- Arm G: Osimertinib (AZD9291) PIS and ICF - arm now closed to recruitment
- Arm H: Sitravatinib PIS and ICF - arm now closed to recruitment
- Arm NA, Cohort NA1: Durvalumab (MEDI4376) PIS and ICF - arm now closed to recruitment
- Arm J: AZD6738 & Durvalumab PIS and ICF [doc, 356 KB]
- Biopsy for Molecular Testing PIS and ICF [doc, 191 KB]
- Voluntary Pre-Trial Biopsy PIS and ICF [doc, 877 KB]
- Voluntary Post-Trial Biopsy PIS and ICF [doc, 860 KB]
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
- Arm A: AZD4547 GP Letter - arm now closed to recruitment
- Arm B: Vistusertib (AZD2014) GP Letter [doc, 823 KB]
- Arm C: Palbociclib GP Letter [doc, 787 KB]
- Arm D: Crizotinib GP Letter [doc, 786 KB]
- Arm E: Selumetinib & Docetaxel GP Letter [doc, 787 KB]
- Arm F: AZD5363 GP Letter - arm now closed to recruitment
- Arm G: Osimertinib (AZD9291) GP Letter - arm now closed to recruitment
- Arm H: Sitravatinib GP Letter - arm now closed to recruitment
- Arm NA, Cohort NA1: Durvalumab (MEDI4376) GP Letter - arm now closed to recruitment
- Arm J: AZD6738 & Durvalumab GP letter [doc, 801 KB]
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.
- Arm A: AZD4547 Patient Diary [pdf, 269 KB]
- Arm B: Vistusertib (AZD2014) Patient Diary [pdf, 265 KB]
- Arm C: Palbociclib Patient Diary [pdf, 282 KB]
- Arm D: Crizotinib Patient Diary [pdf, 271 KB]
- Arm E: Selumetinib & Docetaxel Patient Diary [pdf, 259 KB]
- Arm F: AZD5363 Patient Diary [pdf, 236 KB]
- Arm G: Osimertinib (AZD9291) Patient Diary [pdf, 248 KB]
- Arm H: Sitravatinib Patient Diary [pdf, 600 KB]
- Arm J: AZD6738 & Durvalumab Patient Diary [doc, 720 KB]
Other
- Smoking Questionnaire [pdf, 465 KB]
- Patient ID Card [pdf, 43 KB]
- Release of Medical Information Form [doc, 820 KB]
Pharmacovigilence
- SAE Form [pdf, 282 KB]
- SAE Form Completion Guidelines [pdf, 148 KB]
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.
- Investigator Site File Version Control List [pdf, 142 KB]
- Pharmacy File Version Control List [pdf, 121 KB]
- Feeder Investigator Site File Version Control List [pdf, 102 KB]
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.
- Combined MHRA Approval Documents [pdf, 2,526 KB]
- Combined REC Approval Documents [pdf, 3,934 KB]
- Combined HRA Approval Documents [pdf, 1,515 KB]
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.
- ctDNA Blood Plasma Sample Form [doc, 33 KB]
- Whole Blood Germline DNA Sample Form [doc, 36 KB]
- PBMC Sample Form [doc, 89 KB]
- Mandatory Repeat Biopsy Tumour Sample Form [doc, 25 KB]
- Optional Research Biopsy Tumour Sample Form [doc, 46 KB]
- Instructions for use of Carbon Monoxide Monitors [pdf, 583 KB]
- MicroCO-Meter Operating Manual [pdf, 1,364 KB]
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]