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)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Other: Radiographic surveillanceDrug: Adjuvant ChemotherapyOther: 14-Gene Prognostic Assay
- Registration Number
- NCT01817192
- Lead Sponsor
- Razor Genomics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 420
- 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
- Final pathologic diagnosis of pure squamous cell, pure small cell, or pure neuroendocrine histology, or any combination of only these three histologies
- Evidence of greater than stage IIA pathologic staging
- Evidence of incomplete resection
- Pregnant or lactating women
- Unwilling to use an effective means of contraception
- Active infection, either systemic or at site of primary resection
- Systemic chemotherapy or anti-cancer agent within 5 years prior to enrollment
- Radiotherapy to the chest in the immediate pre- or post- operative period
- Malignancies other than the current NSCLC within 5 years prior to randomization, except for adequately treated CIS of the cervix, non-melanoma skin cancer, localized prostate cancer treated locally, ductal carcinoma in situ treated surgically
- Treatment with any investigational drug or participation in another clinical trial within 28 days prior to enrollment
- Known hypersensitivity to study treatment agents
- Evidence of any other disease including infection that contraindicates the use of systemic cytotoxic chemotherapy or puts the patient at high risk for treatment-related complications
- Wound dehiscence or infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Observation Radiographic surveillance 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. Observation 14-Gene Prognostic Assay 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. Adjuvant Chemotherapy 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. Adjuvant Chemotherapy 14-Gene Prognostic Assay 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.
- Primary Outcome Measures
Name Time Method Disease-Free Survival 5 years To compare Disease Free Survival in patients with resected, stage I or IIA non-squamous NSCLC found to be at intermediate or high risk by the 14-Gene Prognostic Assay randomized to either observation or adjuvant therapy with 4 cycles of a platinum-based doublet.
- Secondary Outcome Measures
Name Time Method Overall Survival 5 years To compare Overall Survival in patients randomized to each study arm. To further document the previously verified separation of the survival curves among high and low risk patients identified by the 14-Gene Prognostic Assay in this prospective cohort of stage I or IIA non-squamous NSCLC.
Trial Locations
- Locations (49)
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
München-Gauting
🇩🇪Gauting, Germany
Niels-Stensen-Kliniken
🇩🇪Georgsmarienhütte, Germany
Hôpital APHP Ambroise Paré
🇫🇷Boulogne, France
Hia Percy
🇫🇷Clamart, France
Centre Hospitalier Intercommunal de Créteil
🇫🇷Créteil, France
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
🇺🇸Ft 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, 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
🇫🇷Besancon, France
Lung Clinic Grosshansdorf-Department of Thoracic Oncology
🇩🇪Grosshansdorf, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Köln-Merheim
🇩🇪Köln, Germany
University Medical Center Schleswig-Holstein
🇩🇪Lübeck, Germany
University Hospital of Munich
🇩🇪München, Germany
Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg
🇩🇪Oldenburg, Germany