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: Recruiting
Location: See all (53) 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
NOT_YET_RECRUITING
Aurora
New York
Clinical Research Alliance
RECRUITING
Westbury
Tennessee
Baptist Cancer Center
RECRUITING
Memphis
Other Locations
Australia
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Royal North Shore Hospital
RECRUITING
St Leonards
Calvary Mater Newcastle
RECRUITING
Waratah
Brazil
Hospital de Cancer de Barretos
RECRUITING
Barretos
Universidade de Caxias do Sul - Rio Grande do Sul
RECRUITING
Caxias Do Sul
Hospital de Clínicas de Porto Alegre X
RECRUITING
Porto Alegre
Hospital Sao Lucas - PUCRS
RECRUITING
Porto Alegre
Hospital de Base de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
Instituto do Cancer do Estado de Sao Paulo - ICESP
RECRUITING
São Paulo
Chile
K2 Oncology
RECRUITING
Providencia
RedSalud Vitacura
RECRUITING
Santiago
China
Beijing Cancer Hospital
RECRUITING
Beijing
Xiangya Hospital of Centre-South University
RECRUITING
Changsha
The third people's hospital of Chengdu
RECRUITING
Chengdu
Guangdong General Hospital
RECRUITING
Guangzhou
Jinhua municipal central hospital
RECRUITING
Jinhua
Yunnan Cancer Hospital
RECRUITING
Kunming
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhejiang Cancer Hospital
RECRUITING
Zhejiang
France
Centre Leon Berard
RECRUITING
Lyon
CHU Timone
RECRUITING
Marseille
CHU de Bordeaux
RECRUITING
Pessac
CHU Strasbourg - Nouvel Hopital Civil
RECRUITING
Strasbourg
Italy
Humanitas Gavazzeni
RECRUITING
Bergamo
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
RECRUITING
Meldola
Asst Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Irccs Istituto Europeo di Oncologia (IEO)
RECRUITING
Milan
IRCCS Istituto Oncologico Veneto (IOV)
RECRUITING
Padua
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
RECRUITING
Perugia
Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
Mexico
ARKE Estudios Clínicos S.A. de C.V.
RECRUITING
Mexico City
Centro Oncologico Internacional
RECRUITING
Mexico City
New Zealand
Auckland City Hospital, Cancer and Blood Research
RECRUITING
Auckland
Poland
Centrum Pulmonologii i Torakochirurgii
RECRUITING
Bystra
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gda?sk
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
RECRUITING
Poznan
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
RECRUITING
Warsaw
Republic of Korea
St. Vincent's Hospital
RECRUITING
Gyeonggi-do
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Regional Universitario Carlos Haya
RECRUITING
Málaga
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Thailand
Faculty of Med. Siriraj Hosp.
RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hosp
RECRUITING
Chang Mai
Oncology Unit, Faculty of Medicine, Vajira Hospital
RECRUITING
Dusit
Srinagarind Hospital
RECRUITING
Khon Kaen
Contact Information
Primary
Reference Study ID Number: BO43249 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2033-03-31
Participants
Target number of participants: 150
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.
Related Therapeutic Areas
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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