• Vanessa Acquaah (chair)

• Caitlin Clunie-O’Connor (programme

  manager)

• Philani Mpofu (Lead Methodologist)

• Patrycja Pluta (Research Scientist)

   

• Jennifer McCaffery (lay)

• Hayley Hall (lay)

• Thomas Smith (patient)

• Sonia Patton (patient)

• Yanrong Jiang (clinical)

No conflicts declared by panel

Approved

• The lay summary provides a clear overview of advanced NSCLC, highlighting a rapidly changing treatment landscape where real-world data (RWD) studies remain limited.

• Clear articulation of patient benefit, with potential to influence UK clinical practice and guide Takeda’s future trial development.

• The explanation of the analytical approach was clear and provided helpful context for understanding the study.

• The patient benefits were clearly outlined and demonstrated the study's potential to identify areas of unmet need. This could lead to more tailored treatments in the future, resulting in improved disease control, enhanced quality of life, and better patient prognoses.

• The panel raised several comments on other aspects of the application including:

   

  • • Further clarification on the reasoning behind the chosen analytical approach? (i.e why certain biomarkers were chosen and how the analysis will take into consideration different demographic groups)
    • More clarification on how Takeda and Flatiron will work together on this project
    • Further details on how outcomes will be disseminated to patients/public and how they may be involved in informing trial design

• • • Further clarification about the comparison of UK Standard of Care with the German Standard of Care