420
Participants
Start Date
September 11, 2020
Primary Completion Date
May 15, 2027
Study Completion Date
May 15, 2027
Adjuvant Chemotherapy
Patients who have undergone complete resection of NSCLC that has been documented histologically to be non-squamous and that is pathological Stage I or IIA, will undergo testing with the 14-Gene Prognostic Assay. Patients determined to be intermediate or high risk and who meet all eligibility criteria will be randomized either to observation or to four cycles of adjuvant therapy with a standard NSCLC platinum-based doublet.
Radiographic surveillance
Serial radiographic surveillance is a current standard of care for Stage I or Stage IIA lung cancer. All intermediate or high risk patients randomized to observation or chemotherapy will have routine CT Scans at 6 month intervals until 5 years after enrollment and at yearly intervals thereafter until the end of the study period.
14-Gene Prognostic Assay
This CLIA-approved assay is a standard tool that is now available to all clinicians to improve the prognostic evaluation of patients after resection of Stage I or Stage IIA non-squamous NSCLC. It will be performed on tumor specimens for patients who are potentially eligible for this study. Patients identified through the assay as intermediate or high-risk will be randomized to either adjuvant chemotherapy or observation.
Hôpital Europeen, Marseille
Hôpital Nord, Marseille
Allegheny Health Network Research Institute, Pittsburgh
Lung Clinic Grosshansdorf-Department of Thoracic Oncology, Großhansdorf
CHRU Besançon- Hôpital J. MINJOZ, Besançon
Sarah Cannon- Messino Cancer Center, Asheville
St. Francis Cancer Center, Greenville
Centre Hospitalier Universitaire de Nîmes, Nîmes
Hôpital Larrey, Toulouse
Sarah Cannon- FCS Panhandle, Tallahassee
Centre Hospitalier de la Côte Basque, Bayonne
Sarah Cannon- FCS East, West Palm Beach
Hôpital Haut-Lévèque (Bordeaux - CHU), Pessac
Sarah Cannon- FCS North, Petersburg
Sarah Cannon- FCS South, Fort Meyers
CHRU de Tours, Tours
Sarah Cannon Tennessee Oncology, Nashville
Baptist Health Louisville, Louisville
Baptist Health Lexington, Lexington
CHU d'Angers Service Pneumologie, Angers
Köln-Merheim, Cologne
Mercy Oncology Research St. Louis, St Louis
Mercy Hospital Joplin Missouri, Joplin
Hôpital Privé Jean Mermoz, Lyon
Mercy Oncology Research Oklahoma City, Oklahoma City
Hôpital Cochin, Paris
Hôpital Tenon, Paris
Hôpital Paris Saint Joseph, Paris
Hôpital Bichat, Paris
Hôpital Charles Nicolle, Rouen
University Hospital of Munich, München
München-Gauting, Gauting
Centre Hospitalier Départemental Vendée, La Roche-sur-Yon
Chu de Poitiers, Poitiers
Hôpital APHP Ambroise Paré, Boulogne
Hia Percy, Clamart
Leonard Cancer Institute, Mission Viejo
Centre Hospitalier Intercommunal de Créteil, Créteil
Gustave Roussy, Villejuif
Providence Medical Foundation Santa Rosa, Santa Rosa
UC Davis Comprehensive Cancer Center, Sacramento
Swedish Cancer Institute, Seattle
Groupe Hospitalier Région de Mulhouse Sud -Alsace, Mulhouse
Hackensack Meridian Health, Neptune City
Polyclinique Bordeaux Nord, Bordeaux
Niels-Stensen-Kliniken, Georgsmarienhütte
Medizinische Hochschule Hannover, Hanover
University Medical Center Schleswig-Holstein, Lübeck
Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg, Oldenburg
Lead Sponsor
Collaborators (1)
Encore Clinical
OTHER
Razor Genomics
INDUSTRY