A Phase I-III, 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
Status: Active_not_recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The objective of this study is to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Cohort B1 is a phase II cohort that will evaluate the safety, and efficacy of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection. Cohort B2 is a phase II cohort that will evaluate the efficacy and safety of perioperative alectinib in combination with chemotherapy in the neoadjuvant setting.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
• Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology
• Documented ALK fusion
Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
Aurora
New York
Clinical Research Alliance
Westbury
Tennessee
Baptist Cancer Center
Memphis
Other Locations
Australia
Sir Charles Gairdner Hospital
Nedlands
Royal North Shore Hospital
St Leonards
Brazil
Hospital de Cancer de Barretos
Barretos
Universidade de Caxias do Sul - Rio Grande do Sul
Caxias Do Sul
Hospital de Clínicas de Porto Alegre X
Porto Alegre
Hospital Sao Lucas - PUCRS
Porto Alegre
Hospital de Base de Sao Jose do Rio Preto
São José Do Rio Preto
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo
Chile
RedSalud Vitacura
Santiago
China
Beijing Cancer Hospital
Beijing
Xiangya Hospital of Centre-South University
Changsha
The third people's hospital of Chengdu
Chengdu
Guangdong General Hospital
Guangzhou
Jinhua municipal central hospital
Jinhua
Yunnan Cancer Hospital
Kunming
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
France
Centre Leon Berard
Lyon
CHU Timone
Marseille
CHU de Bordeaux
Pessac
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg
Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia
Mexico
ARKE Estudios Clínicos S.A. de C.V.
Mexico City
Centro Oncologico Internacional
Mexico City
New Zealand
Auckland City Hospital, Cancer and Blood Research
Auckland
Republic of Korea
St. Vincent's Hospital
Gyeonggi-do
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Regional Universitario Carlos Haya
Málaga
Thailand
Faculty of Med. Siriraj Hosp.
Bangkok
Maharaj Nakorn Chiang Mai Hosp
Chang Mai
Oncology Unit, Faculty of Medicine, Vajira Hospital
Dusit
Srinagarind Hospital
Khon Kaen
Time Frame
Start Date:2024-11-18
Completion Date:2033-03-31
Participants
Target number of participants:11
Treatments
Experimental: Cohort B1
Participants will receive alectinib in combination with platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 5 years.
Experimental: Cohort B2
Participants will receive alectinib and platinum-based chemotherapy for up to 3 cycles (cycle length = 3 weeks) prior to surgery, and alectinib monotherapy after surgery for up to 5 years after surgery.