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

A Phase I-II, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients With Resectable Stage I-III Non-Small Cell Lung Cancer, Selected According to Biomarker Status

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06624059

Acronym

HORIZON 2

Enrollment

Registered

2024-10-02

Start date

2024-11-18

Completion date

2026-07-31

Last updated

2026-08-19

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

Brief summary

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.

Interventions

DRUGAlectinib

Participants will receive oral alectinib twice daily (BID) for up to 2 years.

DRUGCisplatin

Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

DRUGCarboplatin

Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

DRUGPemetrexed

Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Complete resection of the primary NSCLC with negative margins * Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Documented ALK fusion

Exclusion criteria

* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation * Prior exposure to any systemic anti-cancer therapy * Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Design outcomes

Primary

Measure	Time frame
Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy	Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)

Secondary

Measure	Time frame
Incidence, Type, and Severity of AEs With Onset up to 28 Days After the Last Dose of Study Treatment or Until Last on Site/Discontinuation Visit, Whichever Comes First	From first dose to up to approximately 2 years

Countries

Australia, Brazil, Chile, China, Italy, South Korea

Contacts

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026