Resistance Mechanisms and Sequential Treatment Strategies... | NCT06904547

NCT06904547

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Name	Type	Description	Arm Group Labels	Other Names
No intervention administered	Other	No intervention administered
Non Interventional Study	Other	Non Interventional Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mechanisms of resistance to first-line lorlatinib	Reslstance Assessment Liquld Blops-Blood eIDNA NGS Tissue Biopsy (If applicablo)-NGS mechanisms of resistance to first-line lorlatinib Propression pattern Priary ressstance Acquined resistance Moleculsr mechanisms of progression via ctDNA/organize NGS testing. Difference between the mnechsnisins of primary and acquired resistance	24 months

Secondary Outcomes

Measure	Description	Time Frame
Exploring the sequential treatment strategies and their efficacy and safety after first-line progression with lorlatinib	rwTTD1： discontinuation of lorlatinib for any reason (including disease progression, death, severe adverse events, or patient choice) rwTTD2： progression on first-line lorlatinib to discontinuation of the first sequential anti-tumor treatment for any reason (including disease progression, death, severe adverse events, or patient withdrawal from the study) rwORR2: the overall proportion of patients who achieve complete response (CR) and partial response (PR) rwDCR2: the overall proportion of patients who achieve complete response (CR), partial response (PR), and stable disease (SD) rwPFS2: progression on first-line lorlatinib to disease progression or death from any cause or last confirmed survival 6、1-year/2-year-rwPFS2 rate: he proportion of patients who remain progression-free within 1 year/2 years 7、the overall proportion of patients who survive within 1 year/2 years 8、Exploration of the proportion and related reasons for dose adjustment

Other Outcomes

Measure	Description	Time Frame
To determine the optimal sequential treatment strategies for different resistance mechanisms and the impact of these resistance mechanisms on patient outcomes in sequential treatment	Explore the impact of different resistance mechanisms on patient prognosis, and investigate the sequential treatment strategies (including treatment efficacy and safety, if data are available in clinical practice) for ALK-positive locally advanced or metastatic NSCLC patients after resistance to first-line lorlatinib. Through comprehensive genomic analysis, explore which molecular pathological changes can provide guiding information for treatment after lorlatinib resistance, and identify which biomarkers can predict which patients are likely to benefit from specific treatments, thereby formulating individualized treatment plans to improve overall patient efficacy.

Eligibility Module