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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: ALK-Positive NSCLC

Treatments: Other: No intervention administered; Other: Non Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06904547

IS25052

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.