Substantial Amendment 07

  • SA07 MHRA Cover Letter v1.0, 12-Dec-2016 [pdf]
  • SA07 MHRA Acknowledgement of Amendment 16-Dec-2016 [pdf]
  • SA07 MHRA Acceptance of Amendment 16-Jan-2017 [pdf]
  • SA07 REC Cover Letter v1.0, 12-Dec-2016 [pdf]
  • SA07 REC Acknowledgment of Substantial Amendment 13-Dec-2016 [pdf]
  • SA07 REC Favourable Opinion Letter 03-Jan-2017 [pdf]
  • SA07 HRA Confirmation of REC Validation and Categorisation of Amendment 13-Dec-2016 [pdf]
  • SA07 HRA Confirmation of Amendment Assessment 23-Jan-2017 [pdf]
  • SA07 Summary of Protocol v4.0 Changes v1.0, 12-Dec-2016 [pdf]
  • SA07 Summary of Patient Document Changes v1.0 ,25-Nov-2016 [pdf]
  • Trial Protocol v4.0, 12-Dec-2016 [pdf]
  • Trial Protocol Synopsis v4.0, 12-Dec-2016 [pdf]
  • Pharmacy Manual v4.0, 24-Jan-2017 [pdf]
  • Laboratory Manual v4.0 [pdf] 
  • Arm A: Addendum A - Patient Information Sheet & Informed Consent Form v1.0, 24-Nov-2016 [doc]
  • Arm B: Addendum A - Patient Information Sheet & Informed Consent Form v1.0, 24-Nov-2016 [doc]
  • Arm C: Addendum A - Patient Information Sheet & Informed Consent Form v1.0, 24-Nov-2016 [doc]
  • Arm D: Addendum A - Patient Information Sheet & Informed Consent Form v1.0, 24-Nov-2016 [doc]
  • Arm E: Addendum A - Patient Information Sheet & Informed Consent Form v1.0, 24-Nov-2016 [doc]
  • Arm F: Addendum A - Patient Information Sheet & Informed Consent Form v1.0, 24-Nov-2016 [doc]
  • Arm G: Addendum A - Patient Information Sheet & Informed Consent Form v1.0, 24-Nov-2016 [doc]
  • Arm NA, Cohort NA1: Addendum A - Patient Information Sheet & Informed Consent Form v1.0, 24-Nov-2016 [doc]
  • Arm A: AZD4547 – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Arm B: Vistusertib – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Arm C: Palbociclib – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Arm D: Crizotinib – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Arm E: Selumetinib & Docetaxel – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Arm F: AZD5363 – Patient Information Sheet & Informed Consent Form v2.0, 24-Nov-2016 [doc]
  • Arm G: Osimertinib – Patient Information Sheet & Informed Consent Form v2.0, 24-Nov-2016 [doc]
  • Arm NA Cohort NA1: Durvalumab – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Biopsy for Molecular Testing – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Pre-Trial Research Biopsy – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Post-Trial Research Biopsy – Patient Information Sheet & Informed Consent Form v5.0, 24-Nov-2016 [doc]
  • Arm A: AZD4547 – GP Letter v5.0, 24-Nov-2016 [doc]
  • Arm B: Vistusertib – GP Letter v5.0, 24-Nov-2016 [doc]
  • Arm C: Palbociclib – GP Letter v5.0, 24-Nov-2016 [doc]
  • Arm D: Crizotinib – GP Letter v5.0, 24-Nov-2016 [doc]
  • Arm E: Selumetinib & Docetaxel – GP Letter v5.0, 24-Nov-2016 [doc]
  • Arm F: AZD5363 – GP Letter v2.0, 24-Nov-2016 [doc]
  • Arm G: Osimertinib – GP Letter v2.0, 24-Nov-2016 [doc]
  • Arm NA Cohort NA1: Durvalumab – GP Letter v5.0, 24-Nov-2016 [doc]
  • Arm A: AZD4547 – Patient Diary v3.0, 24-Nov-2016 [pdf]
  • Arm B: Vistusertib – Patient Diary v3.0, 24-Nov-2016 [pdf]
  • Arm C: Palbociclib – Patient Diary v3.0, 24-Nov-2016 [pdf]
  • Arm D: Crizotinib – Patient Diary v3.0, 24-Nov-2016 [pdf]
  • Arm E: Selumetinib – Patient Diary v3.0, 24-Nov-2016 [pdf]
  • Arm F: AZD5363 – Patient Diary v2.0, 24-Nov-2016 [pdf]
  • Arm G: Osimertinib – Patient Diary v2.0, 24-Nov-2016 [pdf]
  • Release of Medical Information Form v3.0, 24-Nov-2016 [doc]
  • Patient ID Card v2.0, 24-Nov-2016 [pdf]
  • Registration Form v4.0, 24-Jan-2017 [pdf]
  • Core Eligibility Checklist v3.0, 24-Jan-2017 [pdf]
  • Eligibility Checklist - Arm A AZD4547 v4.0, 23-Jan-2017 [pdf]
  • Eligibility Checklist – Arm B Vistusertib v3.0, 24-Jan-2017 [pdf]
  • Eligibility Checklist – Arm C Palbociclib v5.0, 24-Jan-2017 [pdf]
  • Eligibility Checklist – Arm D Crizotinib v4.0, 24-Jan-2017 [pdf]
  • Eligibility Checklist – Arm E Sel & Doc v3.0, 24-Jan-2017 [pdf]
  • Eligibility Checklist – Arm F AZD5363 v2.0, 24-Jan-2017 [pdf]
  • Eligibility Checklist – NA Cohort NA1 Durvalumab v5.0, 24-Jan-2017 [pdf]