Lung Cancer Clinical Trial
Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer
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 Criteria
Inclusion Criteria:
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
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There are 48 Locations for this study
Springdale Arkansas, 72762, United States
Mission Viejo California, 92961, United States
Sacramento California, 95817, United States More Info
Principal Investigator
Santa Rosa California, 95403, United States More Info
Principal Investigator
Fort Myers Florida, 33916, United States More Info
Principal Investigator
Saint Petersburg Florida, 33705, United States More Info
Principal Investigator
Tallahassee Florida, 32308, United States More Info
Principal Investigator
West Palm Beach Florida, 33401, United States More Info
Principal Investigator
Lexington Kentucky, 40503, United States More Info
Principal Investigator
Sub-Investigator
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Sub-Investigator
Louisville Kentucky, 40207, United States More Info
Principal Investigator
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Sub-Investigator
Paducah Kentucky, 42003, United States
Joplin Missouri, 65804, United States
Saint Louis Missouri, 63128, United States
Saint Louis Missouri, 63141, United States More Info
Principal Investigator
Sub-Investigator
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Sub-Investigator
Sub-Investigator
Neptune New Jersey, 07753, United States More Info
Principal Investigator
Asheville North Carolina, 28803, United States More Info
Principal Investigator
Oklahoma City Oklahoma, 73120, United States
Pittsburgh Pennsylvania, 15212, United States More Info
Principal Investigator
Greenville South Carolina, 29607, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Seattle Washington, 98104, United States More Info
Principal Investigator
Sub-Investigator
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Sub-Investigator
Toulon Cedex 9, 83800, France More Info
Principal Investigator
Bordeaux Cedex, , France More Info
Principal Investigator
Rouen Cedex, 76031, France More Info
Principal Investigator
Angers , 49033, France More Info
Principal Investigator
Bayonne , 33077, France More Info
Principal Investigator
Besancon , 25000, France More Info
Principal Investigator
Boulogne , 92104, France More Info
Principal Investigator
Créteil , 94000, France More Info
Principal Investigator
La Roche-sur-yon , 85925, France More Info
Principal Investigator
Lyon , 69008, France More Info
Principal Investigator
Mulhouse , 68010, France More Info
Principal Investigator
Nîmes , 30029, France More Info
Principal Investigator
Paris , 75674, France More Info
Principal Investigator
Pessac , 33604, France More Info
Principal Investigator
Essen , 45239, Germany More Info
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Principal Investigator
Gauting , 82131, Germany More Info
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Principal Investigator
Georgsmarienhütte , , Germany More Info
Contact
Principal Investigator
Grosshansdorf , 22927, Germany More Info
Principal Investigator
Oldenburg , , Germany More Info
Principal Investigator
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