Pneumologie 2020; 74(S 01): 129-130
DOI: 10.1055/s-0039-3403357
Posterbegehung (PO25) – Sektion Pneumologische Onkologie
NSCLC: Systemtherapie bei molekularem Treiber
Georg Thieme Verlag KG Stuttgart · New York

ALINA: a phase III study of alectinib versus chemotherapy as adjuvant therapy in patients with stage IB-IIIA anaplastic lymphoma kinase-positive (ALK +) non-small cell cancer (NSCLC)

A Rittmeyer
1   Pulmonology, University Medical Center Göttingen
,
B Solomon
2   Peter Maccallum Cancer Centre
,
JS Ahn
3   Samsung Medical Center
,
F Barlesi
4   Aix-Marseille University; Aix-Marseille University, Marseille, France; Assistance Publique-Hopitaux Marseille (Aphm)
,
R Dziadziuszko
5   Medical University of Gdansk
,
M Nishio
6   The Cancer Institute Hospital, Japanese Foundation for Cancer Research; The Cancer Institute Hospital, Tokyo, Japan
,
A Shaw
7   Massachusetts General Hospital
,
W Bordogna
8   F. Hoffmann-La Roche Ltd
,
C Meyenberg
8   F. Hoffmann-La Roche Ltd
,
YL Wu
9   Guangdong Provincial Peopleʼs Hospital & Guangdong Academy of Medical Sciences
› Author Affiliations
Further Information

Publication History

Publication Date:
28 February 2020 (online)

 

Background: Patients with early stage NSCLC (stage IA-IIIA) account for ~ 40% of cases at diagnosis; despite surgery, 5-year survival rates are low. Platinum-based adjuvant chemotherapy is the standard of care for stage IIA-IIIA disease. Although patients with stage IA NSCLC do not benefit from adjuvant chemotherapy, patients with stage IB disease and large tumours (≥ 4 cm) do. Adjuvant chemotherapy produces a 4 – 5% increase in 5-year survival rates, leaving a significant unmet need for improved treatments. Approximately 5% of patients with NSCLC harbour an oncogenic fusion of the ALK gene. Treatment of advanced ALK+ NSCLC with ALK inhibitors improves efficacy and safety compared with chemotherapy. Alectinib, a potent ALK inhibitor, is the standard of care first-line treatment for advanced ALK+ NSCLC. The ongoing ALINA trial will compare alectinib versus chemotherapy as adjuvant treatment for patients with stage IB-IIIA ALK+ NSCLC.

Methods: ALINA (ClinicalTrials.gov: NCT03456076) is a randomised, multicentre, open-label phase III study investigating the efficacy and safety of adjuvant alectinib versus chemotherapy in ALK+ NSCLC (confirmed by an FDA-approved and CE-marked test). Adult patients (≥ 18 years) with completely resected stage IB (tumours ≥ 4 cm) to IIIA disease and Eastern Cooperative Oncology Group performance status 0 – 1 are eligible for inclusion. Patients (N = 255) from ~ 170 centres across ~ 30 countries will be randomised 1 : 1 to receive twice-daily alectinib 600 mg for 24 months or four 21-day cycles of platinum-based chemotherapy (cisplatin 75 mg/m2 [day 1] plus vinorelbine 25 mg/m2 [days 1 and 8] or gemcitabine 1250 mg/m2 [days 1 and 8] or pemetrexed 500 mg/m2 [day 1]) according to local prescribing information. Stratification factors are disease stage (stage IB [≥ 4 cm] versus stage II versus stage IIIA) and race (Asian versus non-Asian). Treatment will continue until planned completion, disease recurrence, unacceptable toxicity, withdrawal of consent, or death; whichever occurs first. The primary endpoint is disease-free survival per investigator; secondary endpoints are overall survival, safety and pharmacokinetics.