Phase II, open label, single arm, multicenter study to assess the activity and safety of ALectinib as NE O adjuvant therapy in patients with anaplastic lymphoma kinase positive (ALK+) locally advanced Stage III Non Small Cell Lung Cancer (NSCLC): ALNEO trial-GOIRC-01-2020

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519106-12-00

Acronym

ALNEO trial-GOIRC-01

Enrollment

Registered

2024-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-02

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

Conditions

Patients with anaplastic lymphoma kinase positive (ALK+) locally advanced Stage III Non Small Cell Lung Cancer (NSCLC)

Brief summary

The primary endpoint is m ajor pathologic response (MPR), defined as <=10% residual viable tumor cells histologically detected in the resected primary tumor and all resected lymph nodes after surgery

Detailed description

Pathological complete response - Pathological complete response (pCR) is defined as the absence of residual viable tumor cells in all specimens as evaluated by BIPR after surgery

Interventions

DRUGALECTINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is m ajor pathologic response (MPR), defined as <=10% residual viable tumor cells histologically detected in the resected primary tumor and all resected lymph nodes after surgery	—

Secondary

Measure	Time frame
Pathological complete response - Pathological complete response (pCR) is defined as the absence of residual viable tumor cells in all specimens as evaluated by BIPR after surgery	—

Countries

Italy

Outcome results

None listed

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