Health-Related QoL of advanced Non-Small-Cell Lung Cancer Patients

• Research type

  Research Study

• Full title

  Health-Related Quality of Life (HRQoL) of advanced Non-Small-Cell Lung Cancer Patients with mutated or unmutated KRAS gene treated in routine care in Germany, France, and the UK

• IRAS ID

  291553

• Contact name

  Colin Lindsay

• Contact email

  Colin.Lindsay@christie.nhs.uk

• Sponsor organisation

  Amgen (Europe) GmbH

• Duration of Study in the UK

  years, 15 months, days

• Research summary

  - Study Background and Rationale: Non-small cell lung cancer (NSCLC) is a life-
  threatening disease, with a heterogeneous profile depending primarily on which genes are mutated and stage of diagnosis. Although patients bearing specific mutations (e.g. EGFR, ALK, BRAF, etc.) have been well studied and have the option of receiving targeted therapies, real-world treated patients bearing the KRAS G12c mutations have not been sufficiently characterized and documented in terms of both their clinical profile and their HRQoL.

  Study Population or Data Resource: Primary collection of PRO data among locally advanced and unresectable or metastatic NSCLC patients with KRAS mutated (G12c or other mutation) or KRAS wildtype tumors who are not on targeted therapies in the index (i.e. 2nd [2L] or 3rd line and beyond [3L+]) line.

  - Research Question and Objective(s):
  - Primary: To describe real-world health-related quality of life (HRQoL) data for
  locally advanced and unresectable or metastatic NSCLC patients on systemic therapies
  with KRAS-mutated (G12C or other KRAS mutation) or KRAS wildtype tumors based on
  established PRO tools
  - Secondary: To describe sociodemographic and clinical characteristics of locally
  advanced and unresectable or metastatic NSCLC patients on systemic therapies with
  KRAS-mutated (G12C or other KRAS mutation) or KRAS wildtype tumors
  - Exploratory: To identify the factors (demographics, disease and treatment
  characteristics and outcomes) correlating positively or negatively

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  20/EM/0302

• Date of REC Opinion

  1 Feb 2021

• REC opinion

  Further Information Favourable Opinion