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Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer: AIM-HIGH (Adjuvant Intervention in Molecular High Risk Patients)
Sponsor: Razor Genomics
Summary
The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.
Official title: A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as Intermediate or High Risk by a 14-Gene Prognostic Assay
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2020-09-11
Completion Date
2027-05-15
Last Updated
2025-04-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (49)
Leonard Cancer Institute
Mission Viejo, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Providence Medical Foundation Santa Rosa
Santa Rosa, California, United States
Sarah Cannon- FCS South
Fort Meyers, Florida, United States
Sarah Cannon- FCS North
Petersburg, Florida, United States
Sarah Cannon- FCS Panhandle
Tallahassee, Florida, United States
Sarah Cannon- FCS East
West Palm Beach, Florida, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Mercy Hospital Joplin Missouri
Joplin, Missouri, United States
Mercy Oncology Research St. Louis
St Louis, Missouri, United States
Hackensack Meridian Health
Neptune City, New Jersey, United States
Sarah Cannon- Messino Cancer Center
Asheville, North Carolina, United States
Mercy Oncology Research Oklahoma City
Oklahoma City, Oklahoma, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
St. Francis Cancer Center
Greenville, South Carolina, United States
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, United States
Swedish Cancer Institute
Seattle, Washington, United States
Polyclinique Bordeaux Nord
Bordeaux, Cedex, France
Hôpital Charles Nicolle
Rouen, Cedex, France
CHU d'Angers Service Pneumologie
Angers, France
Centre Hospitalier de la Côte Basque
Bayonne, France
CHRU Besançon- Hôpital J. MINJOZ
Besançon, France
Hôpital APHP Ambroise Paré
Boulogne, France
Hia Percy
Clamart, France
Centre Hospitalier Intercommunal de Créteil
Créteil, France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France
Hôpital Privé Jean Mermoz
Lyon, France
Hôpital Europeen
Marseille, France
Hôpital Nord
Marseille, France
Groupe Hospitalier Région de Mulhouse Sud -Alsace
Mulhouse, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France
Hôpital Cochin
Paris, France
Hôpital Tenon
Paris, France
Hôpital Paris Saint Joseph
Paris, France
Hôpital Bichat
Paris, France
Hôpital Haut-Lévèque (Bordeaux - CHU)
Pessac, France
Chu de Poitiers
Poitiers, France
Hôpital Larrey
Toulouse, France
CHRU de Tours
Tours, France
Gustave Roussy
Villejuif, France
Köln-Merheim
Cologne, Germany
München-Gauting
Gauting, Germany
Niels-Stensen-Kliniken
Georgsmarienhütte, Germany
Lung Clinic Grosshansdorf-Department of Thoracic Oncology
Großhansdorf, Germany
Medizinische Hochschule Hannover
Hanover, Germany
University Medical Center Schleswig-Holstein
Lübeck, Germany
University Hospital of Munich
München, Germany
Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg
Oldenburg, Germany