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)
Public ClinicalTrials.gov record NCT01817192. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01817192
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Interventions
- Adjuvant Chemotherapy Drug
- Radiographic surveillance Other
- 14-Gene Prognostic Assay Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 10, 2020
- Primary completion
- May 14, 2027
- Completion
- May 14, 2027
- Last update posted
- Apr 12, 2025
2020 – 2027
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Leonard Cancer Institute | Mission Viejo | California | 92961 | — |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Providence Medical Foundation Santa Rosa | Santa Rosa | California | 95403 | — |
| Sarah Cannon- FCS South | Fort Meyers | Florida | 33916 | — |
| Sarah Cannon- FCS North | Petersburg | Florida | 33705 | — |
| Sarah Cannon- FCS Panhandle | Tallahassee | Florida | 32308 | — |
| Sarah Cannon- FCS East | West Palm Beach | Florida | 33401 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Baptist Health Louisville | Louisville | Kentucky | 40207 | — |
| Mercy Hospital Joplin Missouri | Joplin | Missouri | 65804 | — |
| Mercy Oncology Research St. Louis | St Louis | Missouri | 63141 | — |
| Hackensack Meridian Health | Neptune City | New Jersey | 07753 | — |
| Sarah Cannon- Messino Cancer Center | Asheville | North Carolina | 28803 | — |
| Mercy Oncology Research Oklahoma City | Oklahoma City | Oklahoma | 73120 | — |
| Allegheny Health Network Research Institute | Pittsburgh | Pennsylvania | 15212 | — |
| St. Francis Cancer Center | Greenville | South Carolina | 29607 | — |
| Sarah Cannon Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01817192, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01817192 live on ClinicalTrials.gov.