Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention administered, Non Interventional Study.
- Who it may be relevant to
- Registry conditions: ALK-Positive NSCLC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC: A Multi-center, Observational, Prospective Real-world Cohort Study (LORES)
Overview
This is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in China, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with ALK-positive locally advanced or metastatic NSCLC, as well as the efficacy and safety of sequential treatments following lorlatinib resistance in the real-world setting.
Interventions
- Other No intervention administered
No intervention administered - Other Non Interventional Study
Non Interventional Study
Primary outcome measures
- mechanisms of resistance to first-line lorlatinib [Time frame: 24 months]
Secondary outcome measures (1)
- Exploring the sequential treatment strategies and their efficacy and safety after first-line progression with lorlatinib [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Age: Patients aged 18 years or older;
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Documened ALK resrrangemen by approved test (eg.. FisH,IHC. .r NGS).
- first-line loelaninab treatment fom Apr2023-Apr-2027.
- Evidenoe of popression to first-line lorlztinib within 2 weekes.
Exclusion criteria
- Previous treatment with other ALK-TKIs: Patients who have previously received any ALK TKI other than lorlatinib;
- Concomitant medications: Patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06904547 · IS25052