An ambispective, observational, multi-center study of first-line Lorlatinib in patients with ALK-positive non-small cell lung cancer in Korea (Lorlatinib NIS)

Study identification

• EU PAS number:
  EUPAS1000001141
• Study ID:
  1000001141
• Official title and acronym:
  An ambispective, observational, multi-center study of first-line Lorlatinib in patients with ALK-positive non-small cell lung cancer in Korea (Lorlatinib NIS)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  This study is an ambispective, non-interventional, observational, multi-center cohort study of patients who have received lorlatinib as a part of routine clinical practice prescribed by accredited physicians at Korean healthcare centers. No formal comparison group is included in this study. The study includes both retrospective and prospective data collection. The retrospective component will include data from subjects treated with lorlatinib prior to study enrollment, collected from existing medical records. The prospective component will involve the ongoing follow-up of subjects after enrollment. Subjects who are receiving lorlatinib at the time of study enrollment or are eligible for follow-up thereafter may be included in the prospective follow-up, provided that informed consent for study participation has been obtained.; The study can be performed in Korean health care centers where lorlatinib is prescribed to treat adult patients with ALK-positive NSCLC as first-line treatment according to the local label and the Korean National Health Insurance reimbursement criteria.; Each investigator will enroll patients with ALK-positive NSCLC who have discontinued, are currently receiving, or are planned to initiate lorlatinib as first-line treatment.; Approximately 103 adult (≥19 years) patients diagnosed with ALK-positive NSCLC will be enrolled in this study.; All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this noninterventional study is being conducted.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:30/09/2026

Actual:23/09/2026

Study start date

Planned:15/01/2027

Date of final study report

Planned:15/07/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Pharmaceuticals Korea Ltd.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable