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Alectinib and Local Therapy for Optimal Treatment in ALK-Positive non-small cell lung cancer (ALTHEO Study)

Alectinib and Local Therapy for Optimal Treatment in ALK-Positive non-small cell lung cancer (ALTHEO Study) - NEJ069 ALTHEO Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000059583
Enrollment
700
Registered
2025-10-30
Start date
2025-10-20
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

ALK fusion gene-positive lung cancer.

Interventions

None listed

Sponsors

Specified Nonprofit Corporation North East Japan Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who started treatment with Alectinib for advanced or recurrent NSCLC with ALK fusion gene positivity between September 1, 2014 and December 31, 2022.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of ALK-TKI administration prior to alectinib administration (patients with a history of chemotherapy other than ALK-TKI are eligible for inclusion). 2. Patients with meningeal carcinomatosis prior to alectinib administration. 3. Patients who refused to participate in this study based on the informed consent document. 4. Patients whom the principal investigator or co-investigator deemed unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Presence and details of local treatment for brain metastases, and survival outcomes (overall survival [OS], progression-free survival [PFS], and central nervous system progression-free survival [CNS-PFS]). The study includes calculation of the proportion of patients who experienced progression or newly developed brain metastases during alectinib treatment; assessment of the presence and details of local treatment for brain metastases; evaluation of survival outcomes (overall survival [OS], progression-free survival [PFS], and central nervous system progression-free survival [CNS-PFS]); analysis of survival in patients who continued alectinib after receiving additional local treatment for progressive or newly developed brain metastases; and investigation of the impact of new-onset brain metastases on prognosis (OS and PFS).

Countries

Japan

Contacts

Public ContactSusumu Takeuchi

Nippon Medical School Hospital Department of Pulmonary Medicine and Oncology

s-takeuchi@nms.ac.jp03-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026