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

NCT ID: NCT06904547

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-20

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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ALK-Positive NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention administered

No intervention administered

Intervention Type OTHER

Non Interventional Study

Non Interventional Study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ziming Li

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Li Zi ming

Role: CONTACT

18017321562

Other Identifiers

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IS25052

Identifier Type: -

Identifier Source: org_study_id

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