Substanital Amendment 23

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. SA23 MHRA Approval Documents v1.0 [PDF, 659 KB]
  2. SA23 MHRA Cover Letter [404KB]
  3. MHRA CTA Application [1.67MB]
  4. SA23 HRA Approval Documents v1.0 [PDF, 256 KB]
  5. SA23 REC Cover letter [458KB]
  6. SA23 REC Approval Documents v1.0 [PDF, 734 KB]
  7. SA23 Locked Amendment Tool [428KB]
  8. Trial Protocol v11.0 08-Sep-2021 CLEAN [PDF, 5.02 MB]
  9. Trial Protocol v11.0 08-Sep-2021 TRACKED [PDF, 5.02 MB]
  10. Trial Protocol Synopsis 11.0 01-Apr-2021 CLEAN [PDF, 325 KB]
  11. Trial Protocol Synopsis 11.0 01-Apr-2021 TRACKED [PDF, 325 KB]
  12. Summary of Protocol Changes [147KB]
  13. Protocol Signature page v11.0 [184KB]
  14. Arm C: Palbociclib – PIS & ICF v11.0 20-Jul-21 CLEAN [Word, 244 KB]
  15. Arm C: Palbociclib – PIS & ICF v11.0 20-Jul-21 tracked [Word, 247KB]
  16. Arm J: AZD6738 & Durvalumab – PIS & ICF v3.0 22-Jun-21 [Word, 356 KB]
  17. Arm J: AZD6738 & Durvalumab – PIS & ICF v3.0 22-Jun-21 tracked [Word, 359 KB]
  18. Archive Tissue PIS&ICF_v1.0-12-Mar-2021 [Word, 880KB]

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

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