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)

April 10, 2025 updated by: Razor Genomics

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • CHU d'Angers Service Pneumologie
      • Bayonne, France, 33077
        • Centre Hospitalier de la Cote Basque
      • Besancon, France, 25000
        • CHRU Besançon- Hôpital J. MINJOZ
      • Boulogne, France, 92104
        • Hôpital APHP Ambroise Paré
      • Clamart, France, 92141
        • HIA Percy
      • Créteil, France, 94000
        • Centre Hospitalier Intercommunal de Creteil
      • La Roche-sur-yon, France, 85925
        • Centre Hospitalier Départemental VENDEE
      • Lyon, France, 69008
        • Hôpital Privé Jean Mermoz
      • Marseille, France, 13915
        • Hopital Nord
      • Marseille, France, 13291
        • Hôpital Européen
      • Mulhouse, France, 680100
        • Groupe Hospitalier Région de Mulhouse Sud -Alsace
      • Nîmes, France, 30029
        • Centre Hospitalier Universitaire de Nīmes
      • Paris, France, 75877
        • Hôpital Bichat
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75014
        • Hôpital Cochin
      • Paris, France, 75674
        • Hôpital Paris Saint Joseph
      • Pessac, France, 33604
        • Hôpital Haut-Lévèque (Bordeaux - CHU)
      • Poitiers, France, 86021
        • CHU De Poitiers
      • Toulouse, France, 31059
        • Hopital Larrey
      • Tours, France, 37044
        • CHRU De Tours
      • Villejuif, France, 94805
        • Gustave Roussy
    • Cedex
      • Bordeaux, Cedex, France
        • Polyclinique Bordeaux Nord
      • Rouen, Cedex, France, 76031
        • Hopital Charles Nicolle
  • Germany
      • Gauting, Germany, 82131
        • München-Gauting
      • Georgsmarienhütte, Germany
        • Niels-Stensen-Kliniken
      • Grosshansdorf, Germany, 22927
        • Lung Clinic Grosshansdorf-Department of Thoracic Oncology
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Köln, Germany, 51109
        • Köln-Merheim
      • Lübeck, Germany
        • University Medical Center Schleswig-Holstein
      • München, Germany, 80336
        • University Hospital of Munich
      • Oldenburg, Germany
        • Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg
  • United States
    • California
      • Mission Viejo, California, United States, 92961
        • Leonard Cancer Institute
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation Santa Rosa
    • Florida
      • Ft Meyers, Florida, United States, 33916
        • Sarah Cannon- FCS South
      • Petersburg, Florida, United States, 33705
        • Sarah Cannon- FCS North
      • Tallahassee,, Florida, United States, 32308
        • Sarah Cannon- FCS Panhandle
      • West Palm Beach, Florida, United States, 33401
        • Sarah Cannon- FCS East
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40207
        • Baptist Health Louisville
    • Missouri
      • Joplin, Missouri, United States, 65804
        • Mercy Hospital Joplin Missouri
      • St Louis, Missouri, United States, 63141
        • Mercy Oncology Research St. Louis
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Hackensack Meridian Health
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Sarah Cannon- Messino Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Oncology Research Oklahoma City
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network Research Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • St. Francis Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Tennessee Oncology
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Observation
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.
Other: Radiographic surveillance
Serial radiographic surveillance is a current standard of care for Stage I or Stage IIA lung cancer. All intermediate or high risk patients randomized to observation or chemotherapy will have routine CT Scans at 6 month intervals until 5 years after enrollment and at yearly intervals thereafter until the end of the study period.
Other: 14-Gene Prognostic Assay
This CLIA-approved assay is a standard tool that is now available to all clinicians to improve the prognostic evaluation of patients after resection of Stage I or Stage IIA non-squamous NSCLC. It will be performed on tumor specimens for patients who are potentially eligible for this study. Patients identified through the assay as intermediate or high-risk will be randomized to either adjuvant chemotherapy or observation.
Active Comparator: 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.
Other: 14-Gene Prognostic Assay
This CLIA-approved assay is a standard tool that is now available to all clinicians to improve the prognostic evaluation of patients after resection of Stage I or Stage IIA non-squamous NSCLC. It will be performed on tumor specimens for patients who are potentially eligible for this study. Patients identified through the assay as intermediate or high-risk will be randomized to either adjuvant chemotherapy or observation.
Drug: Adjuvant Chemotherapy
Patients who have undergone complete resection of NSCLC that has been documented histologically to be non-squamous and that is pathological Stage I or IIA, will undergo testing with the 14-Gene Prognostic Assay. Patients determined to be intermediate or high risk and who meet all eligibility criteria will be randomized either to observation or to four cycles of adjuvant therapy with a standard NSCLC platinum-based doublet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival
Time Frame: 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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Razor Genomics

Collaborators

Encore Clinical

Investigators

  • Principal Investigator: David R Spigel, MD, Sarah Cannon, the Cancer Institute of HCA Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2020

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

March 16, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimated)

March 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-120888
  • IFCT-2002 (Other Identifier: The French Cooperative Thoracic Intergroup)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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