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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)
NCT01817192 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Adjuvant Chemotherapy
- OTHER Radiographic surveillance
- OTHER 14-Gene Prognostic Assay
Study Locations (20)
Florida
- Sarah Cannon- FCS South — Fort Meyers
- Sarah Cannon- FCS North — Petersburg
- Sarah Cannon- FCS Panhandle — Tallahassee
- Sarah Cannon- FCS East — West Palm Beach
California
- Leonard Cancer Institute — Mission Viejo
- UC Davis Comprehensive Cancer Center — Sacramento
- Providence Medical Foundation Santa Rosa — Santa Rosa
Kentucky
- Baptist Health Lexington — Lexington
- Baptist Health Louisville — Louisville
Missouri
- Mercy Hospital Joplin Missouri — Joplin
- Mercy Oncology Research St. Louis — St Louis
Cedex
- Polyclinique Bordeaux Nord — Bordeaux
- Hôpital Charles Nicolle — Rouen
New Jersey
- Hackensack Meridian Health — Neptune City
North Carolina
- Sarah Cannon- Messino Cancer Center — Asheville
Oklahoma
- Mercy Oncology Research Oklahoma City — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2020-09-11 |
| Est. Completion | 2027-05-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01817192
The ClinicalTrials.gov registry entry for NCT01817192 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Razor Genomics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which Adjuvant Chemotherapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01817192 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01817192 about?
NCT01817192 is a clinical study titled "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)". 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 p...
What is the current status of trial NCT01817192?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 420 participants. The study started on 2020-09-11. Estimated completion is 2027-05-15.
What conditions does trial NCT01817192 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01817192?
The interventions under investigation include: Adjuvant Chemotherapy (DRUG), Radiographic surveillance (OTHER), 14-Gene Prognostic Assay (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01817192?
This trial is sponsored by Razor Genomics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01817192 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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