NCT05015010

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

Phase II, Open-label, Single-arm, Multicenter Study to Assess the Activity and Safety of ALectinib as NEO-adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase-positive (ALK+) Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC): ALNEO Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations. Across this wide spectrum of heterogeneity, there is no single definitive therapeutic approach and the definition of the most effective treatment approach needs a multidisciplinary approach. In this trial we want to test in ALK positive stage III locally advanced NSCLC patients, the efficacy of Alectinib to induce tumor shrinkage when administered before surgery and to reduce the possibility of disease recurrence, with a limited risk of toxicity related, in long term administration after surgery.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Alectinib	600 mg p.o. (four 150 mg capsules) twice daily with food (within 30 minutes after a meal, in the morning and evening).

Timeline

• Start date: 2021-05-20
• Primary completion: 2024-12-28
• Completion: 2026-12-28
• First posted: 2021-08-20
• Last updated: 2024-08-09

Locations

20 sites across 1 country: Italy