Real-world Study of Local Therapy Changes During 1L Lorlatinib in Unresectable ALK+ NSCLC
- Conditions
- Lung Cancer, Non-Small Cell
- Registration Number
- NCT06690541
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief Summary
This real-word study is designed to prospectively explore whether local treatment (surgery, ablation, radiotherapy and others) can prolong the time to treatment discontinuation during 1L lorlatinib treatment in Chinese patients with unresectable ALK+ NSCLC. Participation in this study is not intended to change the routine treatment received as determined by their attending physicians. Patients will be treated according to the routine medical practice in terms of visit frequency and types of assessments performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time-to treatment discontinuation (TTD) From November 2024 to April 2027 Time-to treatment discontinuation is defined as the time from start of treatment to the date of discontinuation of these therapeutic methods.
- Secondary Outcome Measures
Name Time Method Intracranial Objective Response Rate (IC-ORR) From November 2024 to April 2027 proportion of patients with intracranial objective response of complete response (CR) or partial response (PR) as a best response in the subset of patients with at least 1 intracranial lesion assessed by investigator.
Intracranial Time to Progression (IC-TTP) From November 2024 to April 2027 Time from inclusion to the date of the first documentation of disease progression of intracranial disease, based on either new brain metastases or progression of existing brain metastases.
Objective Response Rate (ORR) From November 2024 to April 2027 proportion of patients with a Complete Response (CR) or Partial Response (PR) as a best response during the lorlatinib treatment. Responses to treatment will be defined according to investigator
Duration of response (DOR) From November 2024 to April 2027 time between the first documentation of objective response and the first documentation of disease progression or death from any cause whichever occurred first, for participants with a confirmed objective response of CR or PR.
Time to Progression (TTP) From November 2024 to April 2027 Based on Investigator's Assessment
Overall Survival (OS) From November 2024 to April 2027 Time from inclusion to date of death from any cause.
Safety: To explore the adverse events (AEs), the dose modification and the reason for interruption or discontinuation of lorlatinib in first line for Chinese patients with ALK-positive locally advanced or metastatic NSCLC recorded in medical records From November 2024 to April 2027 Proportion of patients experiencing a 10-points change from baseline in total score for the EORTC QLQ-C30 From November 2024 to April 2027 evaluate Health-related Quality of life (HRQoL) of ALK- positive locally advanced or metastatic NSCLC patients treated with lorlatinib in first-line using the EORTC QLQ-C30 questionnaires
Dynamic molecular response From November 2024 to April 2027 Mutational Analysis; measured by next-generation sequencing (NGS) if available in real world setting;
Safety and tolerability of the therapeutic changing mode From November 2024 to April 2027 Safety profile according to CTCAE v.5