Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06904547

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

ALK-positive NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention administered

Other

No intervention administered

Non interventional study

Other

Non Interventional Study

Primary outcomes

  1. mechanisms of resistance to first-line lorlatinib

    Time frame: 24 months

    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

Secondary outcomes

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

    Time frame: 24 months

    • 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

  1. To determine the optimal sequential treatment strategies for different resistance mechanisms and the impact of these resistance mechanisms on patient outcomes in sequential treatment

    Time frame: 24 months

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Zi ming

CONTACT

[email protected]

18017321562

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Apr 1, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.