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

Who is this study for? Patients with Stage I or Stage IIA non-small cell lung cancer
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Written informed consent

• Age ≥ 18 years

• Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy according to local institutional standards and likely compliance with follow-up for anticipated length of study (i.e. 5 years from the initiation of enrollment).

• Willing to be randomized to chemotherapy.

• Histologically documented completely resected (R0) Stage I or IIA non-squamous NSCLC (per 8th edition, TNM staging system)

• Adequate tissue sample for the 14-Gene Prognostic Assay

• Life expectancy excluding NSCLC diagnosis ≥ 5 years

• ECOG performance status 0-1

• Completely healed incisions

Locations
United States
Arkansas
Highlands Oncology Group
Recruiting
Springdale
California
Leonard Cancer Institute
Recruiting
Mission Viejo
UC Davis Comprehensive Cancer Center
Recruiting
Sacramento
Providence Medical Foundation Santa Rosa
Recruiting
Santa Rosa
Florida
Sarah Cannon- FCS South
Recruiting
Fort Myers
Sarah Cannon- FCS North
Recruiting
Saint Petersburg
Sarah Cannon- FCS Panhandle
Recruiting
Tallahassee
Sarah Cannon- FCS East
Recruiting
West Palm Beach
Kentucky
Baptist Health Lexington
Recruiting
Lexington
Baptist Health Louisville
Recruiting
Louisville
Baptist Health Paducah
Recruiting
Paducah
Missouri
Mercy Hospital Joplin Missouri
Recruiting
Joplin
Mercy Hospital South
Active, not recruiting
Saint Louis
Mercy Oncology Research St. Louis
Recruiting
Saint Louis
North Carolina
Sarah Cannon- Messino Cancer Center
Recruiting
Asheville
New Jersey
Hackensack Meridian Health
Recruiting
Neptune
Oklahoma
Mercy Oncology Research Oklahoma City
Recruiting
Oklahoma City
Pennsylvania
Allegheny Health Network Research Institute
Recruiting
Pittsburgh
South Carolina
St. Francis Cancer Center
Recruiting
Greenville
Tennessee
Sarah Cannon Tennessee Oncology
Recruiting
Nashville
Washington
Swedish Cancer Institute
Recruiting
Seattle
Other Locations
France
CHU d'Angers Service Pneumologie
Recruiting
Angers
Centre Hospitalier de la Côte Basque
Recruiting
Bayonne
CHRU Besançon- Hôpital J. MINJOZ
Recruiting
Besancon
Polyclinique Bordeaux Nord
Recruiting
Bordeaux
Hôpital APHP Ambroise Paré
Recruiting
Boulogne
Hia Percy
Not yet recruiting
Clamart
Centre Hospitalier Intercommunal de Créteil
Recruiting
Créteil
Centre Hospitalier Départemental Vendée
Recruiting
La Roche-sur-yon
Hôpital Privé Jean Mermoz
Recruiting
Lyon
Hôpital Europeen
Recruiting
Marseille
Hôpital Nord
Recruiting
Marseille
Groupe Hospitalier Région de Mulhouse Sud -Alsace
Recruiting
Mulhouse
Centre Hospitalier Universitaire de Nîmes
Recruiting
Nîmes
Hôpital Bichat
Recruiting
Paris
Hôpital Cochin
Recruiting
Paris
Hôpital Paris Saint Joseph
Recruiting
Paris
Hôpital Tenon
Recruiting
Paris
Hôpital Haut-Lévèque (Bordeaux - CHU)
Recruiting
Pessac
Chu de Poitiers
Recruiting
Poitiers
Hôpital Charles Nicolle
Recruiting
Rouen
Toulon HIA Sainte Anne-
Recruiting
Toulon
Hôpital Larrey
Recruiting
Toulouse
CHRU de Tours
Recruiting
Tours
Gustave Roussy
Not yet recruiting
Villejuif
Germany
Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -
Recruiting
Essen
München-Gauting
Recruiting
Gauting
Munich-Gauting -Thoracic Oncology Department Asklepios Lung Clinic
Recruiting
Gauting
Niels-Stensen-Kliniken
Recruiting
Georgsmarienhütte
Lung Clinic Grosshansdorf-Department of Thoracic Oncology
Recruiting
Grosshansdorf
Köln-Merheim
Recruiting
Köln
Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg
Recruiting
Oldenburg
Contact Information
Primary
Michael Mann, MD
mmann@encoreclinical.org
650-535-0030
Backup
Carolyn Clary, RN
cclary@encoreclinical.org
650-535-0030
Time Frame
Start Date: September 11, 2020
Estimated Completion Date: May 15, 2025
Participants
Target number of participants: 1050
Treatments
Active Comparator: Observation
Post-operative observation of Stage I or Stage IIA non squamous non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as low risk will be observation. Those patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.
Active Comparator: Adjuvant Chemotherapy
Adjuvant Chemotherapy is a current standard of care for intermediate or high-risk Stage I or Stage IIA non-squamous non-small cell lung cancer. Patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Observation Arm.
Sponsors
Leads: Razor Genomics
Collaborators: Encore Clinical

This content was sourced from clinicaltrials.gov

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