Substantial Amendment 19

Please ensure that you have obtained local R&D approval for this amendment before using these documents. All documents require a username and password login to access; please contact the Trial Office if you require these. 

  1. SA19 MHRA Approval Documents v1.0 [PDF, 602 KB]
  2. SA19 HRA Approval Documents v1.0 [PDF, 1,125 KB]
  3. SA19 REC Approval Documents v1.0 [PDF, 658 KB]
  4. Notification of Substantial Amendment (annex 2) form (PDF) 14-Feb-2020 [PDF, 160 KB]
  5. Trial Protocol v9.0 22-Jan-2020 CLEAN [PDF, 5,016 KB]
  6. Trial Protocol v9.0 22-Jan-2020 TRACKED [PDF, 4,994 KB]
  7. Summary of Protocol changes v1.0 22-Jan-2020 [PDF, 1,031 KB]
  8. Trial Protocol Synopsis 9.0 22-Jan-2020 CLEAN [PDF, 130 KB]
  9. Trial Protocol Synopsis 9.0 22-Jan-2020 TRACKED [PDF, 130 KB]
  10. Investigator’s Brochure - AZD6738 v7.0 16-Nov-2018  [PDF not available via website]
  11. Investigator’s Brochure - Durvalumab v14.0  11-Feb-2019 CLEAN [PDF not available via website]
  12. Investigator’s Brochure - Durvalumab v14.0  11-Feb-2019 TRACKED [PDF not available via website]
  13. IMP labels – AZD6738 bottle 08-Jan-2020 [PDF, 1,070 KB]
  14. IMP labels – Durvalumab vial  08-Jan-2020  [PDF, 1,059 KB]
  15. IMP labels – Durvalumab IV bag 08-Jan-2020 [PDF, 1,038 KB]
  16. IMP labels – Durvalumab carton 08-Jan-2020 [PDF, 1,031 KB]
  17. Statement of GMP Compliance – Catalent (Durvalumab) 25-Jul-2018 [PDF, 3,759 KB]
  18. CGMP & Manufacturing Authorisation Statement – Catalent (Durvalumab) 29-Jan-2019 [PDF, 625 KB]
  19. CGMP & Manufacturing Authorisation Statement – Catalent (Durvalumab) 11-Nov-2019 [PDF, 151 KB]
  20. Letter of Access for Clinical Trial Application – AstraZeneca (AZD6738) 16-Jan-2020 [PDF, 85 KB]
  21. Letter of Access for Clinical Trial Application – AstraZeneca (AZD4547)  06-Jun-2018 [PDF, 75 KB]
  22. Letter of Access for Clinical Trial Application – AstraZeneca (Vistusertib) 30-Jan-2020 [PDF, 109 KB]
  23. Letter of Access for Clinical Trial Application – AstraZeneca (Durvalumab) 27-Jan-2020  [PDF, 26 KB]
  24. Clarification Statement – Fisher Clinical Services  [PDF, 41 KB]
  25. Manufacturer’s Authorisation – Almac  07-Feb-2018 [PDF, 95 KB]
  26. Manufacturer’s Authorisation – AstraZeneca Molndal 24-Jan-2019 [PDF, 134 KB]
  27. Manufacturer’s Authorisation – Catalent  14-Mar-2018 [PDF, 98 KB]
  28. Manufacturer’s Authorisation – Fisher Clinical Services 30-Jan-2019 [PDF, 4,762 KB]
  29. Manufacturer’s Authorisation – Medimmune Ltd Cambridge 15-Mar-2017 [PDF, 1,154 KB]
  30. Manufacturer’s Authorisation – Medimmune Pharma Nijmegen 30-Mar-2017 [PDF, 99 KB]
  31. Manufacturer’s Authorisation – Medimmune UK Ltd 14-Sep-2018 [PDF, 123 KB]
  32. Manufacturer’s Authorisation – AstraZeneca Macclesfield 02-Jul-2018 [PDF, 1,289 KB]
  33. Manufacturer’s Authorisation – Vetter Pharma Fertigung Ravensbury 28-Jul-2015 [PDF, 1,796 KB]
  34. QP Declaration – Durvalumab 50mg/ml 18-May-2019 [PDF, 147 KB]
  35. Trial Management Group (TMG) letter of support 16-Dec-2019 [PDF, 130 KB]
  36. Trial Steering Committee (TSC) letter of support 09-Jan-2020 [PDF, 70 KB]
  37. Arm B: Vistusertib – PIS & ICF v8.0 12-Dec-19 CLEAN [Word, 265 KB]
  38. Arm B: Vistusertib – PIS & ICF v8.0 12-Dec-19 TRACKED [Word, 265 KB]
  39. Arm C: Palbociclib – PIS & ICF v9.0 12-Dec-19 CLEAN [Word, 252 KB]
  40. Arm C: Palbociclib – PIS & ICF v9.0 12-Dec-19 TRACKED [Word, 255 KB]
  41. Arm D: Crizotinib – PIS & ICF v8.0 12-Dec-19 CLEAN [Word, 254 KB]
  42. Arm D: Crizotinib – PIS & ICF v8.0 12-Dec-19 TRACKED [Word, 256 KB]
  43. Arm E: Selumetinib & Docetaxel – PIS & ICF v8.0 12-Dec-19 CLEAN [Word, 482 KB]
  44. Arm E: Selumetinib & Docetaxel – PIS & ICF v8.0 12-Dec-19 TRACKED [Word, 484 KB]
  45. Arm J: AZD6738 & Durvalumab – PIS & ICF v1.0 12-Dec-19 [Word, 552 KB]
  46. Arm J: AZD6738 & Durvalumab – GP Letter v1.0 12-Dec-19 [Word, 779 KB]
  47. Arm J: AZD6738 & Durvalumab – Patient Diary v1.0 12-Dec-19 [Word, 699 KB]
  48. Release of Medical Information Form v6.0 12-Dec-19 CLEAN [Word, 798 KB]
  49. Release of Medical Information Form v6.0 12-Dec-19 TRACKED [Word, 803 KB]
  50. Summary of Patient Document Changes v1.0 16-Dec-19 [PDF, 320 KB]

Please note: Investigators Brochures (IBs) will be sent to sites via email.

Please note: Patient Documents should be localised using hospital headed paper.