Multi center observational study of resistance mechanisms to alectinib in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer

Multi center observational study of resistance mechanisms to alectinib in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer - ALCURE(ALeCtinib Ultimate REsistance mechanisms study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038934

Enrollment

200

Registered

2019-12-19

Start date

2019-12-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients 20 years of age or older at the time of signed consent. (2)Patients with locally advanced or metastatic ALK-rearranged non-small cell lung cancer. (3)Patients who treated with or are scheduled to start alectinib as first-line, based on the alectinib package insert. (4)Patients who can submit a tissue sample collected before alectinib is administered. (5)Patients who signed informed consent form before enrolling the study.

Exclusion criteria

Exclusion criteria: (1)Patients who are judged by physician in charge of a case to be inappropriate to participate in study.

Design outcomes

Primary

Measure	Time frame
To explore the resistance mechanisms to alectinib and relationship between the resistance mechanisms and efficacy of first-line alectinib and second-line therapy	—

Secondary

Measure	Time frame
To establish the patient derived cancer cell line and analyze the resistance mechanisms besides secondary mutations in ALK, and to analyze the immune microenvironment in ALK rearranged cancer	—

Countries

Japan

Contacts

Public ContactThe ALCURE Study Research Secretariat

EP-CRSU Co.,Ltd. Clinical Research Headquarters

prj-alcure@eps.co.jp03-5804-5045

Outcome results