Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib In Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506859-13-00

Acronym

BO28984

Enrollment

Registered

2024-07-17

Start date

2014-09-09

Completion date

2025-03-14

Last updated

2025-04-22

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

Conditions

Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)

Brief summary

1. PFS, as assessed by investigator

Detailed description

1. PFS by IRC, 2. Time to CNS Progression by IRC, 3. ORR as determined by the investigators using RECIST v1.1., 4. DOR, 5. Time to deterioration (TTD) in patient-reported lung cancer symptoms, 6. Health-related quality of life (HRQoL), 7. Safety and tolerability, 8. Pharmacokinetics of alectinib and metabolite(s), 9. Overall survival (OS)

Interventions

DRUGXALKORI 200 mg hard capsules

DRUGAlecensa 150 mg hard capsules

DRUGAlectinib (Alecensa)

DRUGXALKORI 250 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. PFS, as assessed by investigator	—

Secondary

Measure	Time frame
1. PFS by IRC, 2. Time to CNS Progression by IRC, 3. ORR as determined by the investigators using RECIST v1.1., 4. DOR, 5. Time to deterioration (TTD) in patient-reported lung cancer symptoms, 6. Health-related quality of life (HRQoL), 7. Safety and tolerability, 8. Pharmacokinetics of alectinib and metabolite(s), 9. Overall survival (OS)	—

Countries

Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026