Phase I/II study of AF802 in patients with Non-Small Cell Lung Cancer harboring ALK fusion gene

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221227

Enrollment

Registered

2010-09-03

Start date

2010-09-03

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

investigational material(s) Generic name etc : AF802 INN of investigational material : alectinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Those patients who have been confirmed histologically or cytologically to have non-small cell lung cancer. -Those patients whose tumor samples related to non-small cell lung cancer are confirmed to be positive for ALK fusion gene expression. -Those patients who have received 2 or more chemotherapy regimens.(Phase1) -Those patients who have received 1 or more chemotherapy regimens.(Phase2)

Exclusion criteria

Exclusion criteria: -Those patients who have been treated with an ALK inhibitor in the past. -Those patients who are currently under other investigational treatment

Design outcomes

Primary

Measure	Time frame
Safety, PK parameters (Phase 1) Response rate (Phase 2)	—

Secondary

Measure	Time frame
Tumor regression effect (Phase 1) Safety, Efficacy, PK parameters (Phase 2)	—

Outcome results

None listed

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