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