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A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Hoffmann-La Roche
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2024-11-18
Completion Date
2026-08-28
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Alectinib
Participants will receive oral alectinib twice daily (BID) for up to 2 years.
Cisplatin
Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Carboplatin
Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Pemetrexed
Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Locations (11)
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
RedSalud Vitacura
Santiago, Chile
Beijing Cancer Hospital
Beijing, China
The third people's hospital of Chengdu
Chengdu, China
Guangdong General Hospital
Guangzhou, China
Jinhua municipal central hospital
Jinhua, China
Yunnan Cancer Hospital
Kunming, China
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, Italy
Asan Medical Center
Seoul, South Korea