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NCT06624059 · ClinicalTrials.gov record · last posted 2026-08-19

A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)

Study acronym: HORIZON 2
StatusCompleted
PhasePhase 3
Started2024-11-18
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The objective of this study is to explore the safety of alectinib in combination with chemotherapy in participants with resectable NSCLC. Cohort B1 is a phase II cohort that will assess the safety of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection.

Protocol amendment history 7 changes detected by DataLookout

2026-08-20
Trial completed
2026-08-20
Phase changed: Phase 1/2 → Phase 3
2026-04-09
Phase changed: Phase 3 → Phase 1/2
2026-04-09
Primary endpoint(s) modified
WasCohort B1: Incidence, type, and severity of adverse events (AEs) with onset up to 28 days after the last dose of chemotherapy, Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)
NowIncidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy
2026-04-09
Trial arms changed: 2 → 1
2026-04-09
Primary completion moved earlier: 2028-06-13 → 2026-08-28
2026-04-09
Completion moved earlier: 2033-03-31 → 2026-08-28
Trial Details
NCT Number NCT06624059
Lead Sponsor Hoffmann-La Roche
Conditions Non-Small Cell Lung Cancer
Enrollment 11 participants
Start Date 2024-11-18
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-19