Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC

N/ANot Yet RecruitingNCT06904547

Shanghai Chest Hospital100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

ALK-Positive NSCLC

Interventions

No intervention administeredOTHER

No intervention administered

Non Interventional StudyOTHER

Non Interventional Study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Age: Patients aged 18 years or older; 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC 3. Documened ALK resrrangemen by approved test (eg.. FisH,IHC. .r NGS). 4. first-line loelaninab treatment fom Apr2023-Apr-2027. 5. Evidenoe of popression to first-line lorlztinib within 2 weekes. Exclusion Criteria 1. Previous treatment with other ALK-TKIs: Patients who have previously received any ALK TKI other than lorlatinib; 2. Concomitant medications: Patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.

Outcomes

Primary Outcomes

mechanisms of resistance to first-line lorlatinib

Reslstance Assessment 1. Liquld Blops-Blood eIDNA NGS 2. Tissue Biopsy (If applicablo)-NGS mechanisms of resistance to first-line lorlatinib 1. Propression pattern * Priary ressstance * Acquined resistance 2. Moleculsr mechanisms of progression via ctDNA/organize NGS testing. 3. Difference between the mnechsnisins of primary and acquired resistance

Time frame: 24 months

Secondary Outcomes

Exploring the sequential treatment strategies and their efficacy and safety after first-line progression with lorlatinib

1. rwTTD1： discontinuation of lorlatinib for any reason (including disease progression, death, severe adverse events, or patient choice) 2. 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) 3. rwORR2: the overall proportion of patients who achieve complete response (CR) and partial response (PR) 4. rwDCR2: the overall proportion of patients who achieve complete response (CR), partial response (PR), and stable disease (SD) 5. 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

Time frame: 24 months

Central Contacts

Li Zi ming

CONTACT

18017321562 liziming1980@163.com

Data from ClinicalTrials.gov

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