Disease Registry on Patients with Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Non-small cell lung cancer
• Additional medical condition(s):
  METex14 Skipping Alterations

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  700

Study design details

• Main study objective:
  It will aim to collect prospectively (with longitudinal follow-up) high-quality, standardized, & contemporaneous data to capture changes in the NSCLC treatment landscape & outcomes over time. The registry would capture data on patient and clinical characteristics treatment patterns, and effectiveness and safety outcomes for advanced NSCLC METex14 patients treated with systemic therapy.
• Outcomes:
  Best Overall Response (BOR), Overall Survival (OS), Number of Participants with Adverse Events (AEs), and Number of Participants with Adverse Reactions (ARs)
• Data analysis plan:
  Not applicable