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Active (not recruiting) Phase 1/2 NCT06624059

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

Phase 1/2 – combined early trial
Conditions: Non-Small Cell Lung Cancer

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 6
Australia (1)
Royal North Shore Hospital
St Leonards , New South Wales
Brazil (1)
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo , São Paulo
Chile (1)
RedSalud Vitacura
Santiago
China (1)
Beijing Cancer Hospital
Beijing
Italy (1)
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia , Umbria
South Korea (1)
Asan Medical Center
Seoul
Technical details
Status
Active (not recruiting)
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
18.11.2024
Completion date
28.08.2026
Registry ID
NCT06624059
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.