A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients with Completely Resected Stage Ib (Tumors ≥ 4 Cm) to Stage IIIa Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506861-76-00

Acronym

BO40336

Enrollment

Registered

2024-05-21

Start date

2018-08-09

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Completely resected, Stage Ib (tumors ≥ 4 cm) to Stage IIIa, Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)

Brief summary

1. Disease-free survival per investigator’s assessment

Detailed description

1. Overall survival, 2. Incidence of adverse events, with severity determined through use of National Cancer Institute Common Terminology Criteria for Adverse Events version 45.0, 3. Incidence of abnormal laboratory findings, 4. Changes in vital signs and electrocardiograms, 5. Plasma concentrations of alectinib and its major metabolite(s) at specified timepoints for alectinib

Interventions

DRUGCisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGAlecensa 150 mg hard capsules

DRUGCarboplatin-GRY® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGVINORELBINE

DRUGCarboplatin ACTAVIS 10 mg/ml concentrat pentru soluţie perfuzabilă

DRUGGemcitabin-GRY 1000 mg Pulver zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Disease-free survival per investigator’s assessment	—

Secondary

Measure	Time frame
1. Overall survival, 2. Incidence of adverse events, with severity determined through use of National Cancer Institute Common Terminology Criteria for Adverse Events version 45.0, 3. Incidence of abnormal laboratory findings, 4. Changes in vital signs and electrocardiograms, 5. Plasma concentrations of alectinib and its major metabolite(s) at specified timepoints for alectinib	—

Countries

Austria, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

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