The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Official Title: A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6)
Study ID: NCT03693300
Brief Summary: This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) every 4 weeks \[q4w\] in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT). This study will be conducted in Europe and North America.
Detailed Description: This is a Phase II, open-label, multi-centre study to determine safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) monotherapy in participants with unresectable Stage III NSCLC who have not progressed following definitive, platinum-based sCRT. Approximately, 150 participants will be treated with the study drug in Europe and North America. Participants will be in complete response (CR), partial response (PR), or have stable disease (SD) following definitive, platinum-based sCRT, as assessed by the Investigator and further supported by the screening imaging radiological assessment. Participants must not have progressed following definitive, platinum-based sCRT; radiation therapy must be completed within 42 days prior to first Investigational product (IP) dose administration. Participants must have histologically- or cytologically-documented NSCLC and locally-advanced, unresectable Stage III disease. Participants will be treated with the study drug in 2 cohorts: approximately 100-120 participants in the World Health Organization/Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) 0 to 1 Cohort and up to 30 participants in the WHO/ECOG PS 2 Cohort.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Gainesville, Georgia, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Creteil, , France
Research Site, Paris Cedex 05, , France
Research Site, Saint Priest en Jarez, , France
Research Site, Toulouse Cedex 9, , France
Research Site, Gauting, , Germany
Research Site, Großhansdorf, , Germany
Research Site, Hamm, , Germany
Research Site, Hannover, , Germany
Research Site, Heidelberg, , Germany
Research Site, Avellino, , Italy
Research Site, Meldola, , Italy
Research Site, Milano, , Italy
Research Site, Monza, , Italy
Research Site, Parma, , Italy
Research Site, Roma, , Italy
Research Site, Barcelona, , Spain
Research Site, Guadalajara, , Spain
Research Site, Madrid, , Spain
Research Site, Sevilla, , Spain
Research Site, Valencia, , Spain
Research Site, Leeds, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Middlesbrough, , United Kingdom
Research Site, Nottingham, , United Kingdom
Research Site, Sheffield, , United Kingdom
Research Site, Stoke on Trent, , United Kingdom