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NCT01817192 · ClinicalTrials.gov registry record · NA

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)

A NA study of Non-Small Cell Lung Cancer, sponsored by Razor Genomics.

Active
Registry status
NA
Development phase
420
Enrollment target
20
Study locations

NCT01817192: Active NA study of Non-Small Cell Lung Cancer, sponsored by Razor Genomics.

NCT01817192 is a NA study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Razor Genomics. The registered enrollment target is 420 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01817192, a NA study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Razor Genomics.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
420 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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.

Conditions Studied

Non-Small Cell Lung Cancer

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

FieldValue
Enrollment Target 420 participants
Start Date 2020-09-11
Est. Completion 2027-05-15
Phase NA
Razor Genomics

1 total trials

What the registry record for NCT01817192 still lists

NCT01817192 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (35% lower).

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.

NCT01817192 names 20 study sites across 12 states, led by Florida, California, Kentucky.

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.

What interventions are being tested in trial NCT01817192?

The interventions under investigation include: Adjuvant Chemotherapy (DRUG), Radiographic surveillance (OTHER), 14-Gene Prognostic Assay (OTHER).

Who is sponsoring clinical trial NCT01817192?

This trial is sponsored by Razor Genomics, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01817192's enrollment target sits among peer trials

420 92nd of 454 higher than 360 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01817192, the US trial registry maintained by the National Library of Medicine. NCT01817192 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.