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Non-Small Cell Lung CancerNCT01817192

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 study testing Adjuvant Chemotherapy, Radiographic surveillance and 14-Gene Prognostic Assay in people with Non-Small Cell Lung Cancer, run by Razor Genomics at 49 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Adjuvant Chemotherapy, Radiographic surveillance and 14-Gene Prognostic Assay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
49 sitesin 3 countries
Study dates
11 Sep 2020to 15 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

49 sites in 3 countries.

49 sites in 3 countries

France23 sites

  • CHU d'Angers Service Pneumologie

    Angers, 49033

  • Centre Hospitalier de la Côte Basque

    Bayonne, 33077

  • CHRU Besançon- Hôpital J. MINJOZ

    Besançon, 25000

  • Polyclinique Bordeaux Nord

    Bordeaux, Cedex

  • Hôpital APHP Ambroise Paré

    Boulogne, 92104

  • Hia Percy

    Clamart, 92141

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85925

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

  • Hôpital Europeen

    Marseille, 13291

  • Hôpital Nord

    Marseille, 13915

  • Groupe Hospitalier Région de Mulhouse Sud -Alsace

    Mulhouse, 680100

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Tenon

    Paris, 75020

  • Hôpital Paris Saint Joseph

    Paris, 75674

  • Hôpital Bichat

    Paris, 75877

  • Hôpital Haut-Lévèque (Bordeaux - CHU)

    Pessac, 33604

  • Chu de Poitiers

    Poitiers, 86021

  • Hôpital Charles Nicolle

    Rouen, Cedex, 76031

  • Hôpital Larrey

    Toulouse, 31059

  • CHRU de Tours

    Tours, 37044

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

United States18 sites

  • Sarah Cannon- Messino Cancer Center

    Asheville, North Carolina, 28803

  • Sarah Cannon- FCS South

    Fort Meyers, Florida, 33916

  • St. Francis Cancer Center

    Greenville, South Carolina, 29607

  • Mercy Hospital Joplin Missouri

    Joplin, Missouri, 65804

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

  • Leonard Cancer Institute

    Mission Viejo, California, 92961

  • Sarah Cannon Tennessee Oncology

    Nashville, Tennessee, 37203

  • Hackensack Meridian Health

    Neptune City, New Jersey, 07753

  • Mercy Oncology Research Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Sarah Cannon- FCS North

    Petersburg, Florida, 33705

  • Allegheny Health Network Research Institute

    Pittsburgh, Pennsylvania, 15212

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Providence Medical Foundation Santa Rosa

    Santa Rosa, California, 95403

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Mercy Oncology Research St. Louis

    St Louis, Missouri, 63141

  • Sarah Cannon- FCS Panhandle

    Tallahassee, Florida, 32308

  • Sarah Cannon- FCS East

    West Palm Beach, Florida, 33401

Other trials in United States

Germany8 sites

  • Köln-Merheim

    Cologne, 51109

  • München-Gauting

    Gauting, 82131

  • Niels-Stensen-Kliniken

    Georgsmarienhütte

  • Lung Clinic Grosshansdorf-Department of Thoracic Oncology

    Großhansdorf, 22927

  • Medizinische Hochschule Hannover

    Hanover

  • University Medical Center Schleswig-Holstein

    Lübeck

  • University Hospital of Munich

    München, 80336

  • Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg

    Oldenburg

Other trials in Germany

About this study

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

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.

Being tested
Adjuvant Chemotherapy, Radiographic surveillance, 14-Gene Prognostic Assay
Keywords
Non-Squamous, Adjuvant Chemotherapy, IFCT
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant ChemotherapyDrug

    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.

  • Radiographic surveillanceOther

    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.

  • 14-Gene Prognostic AssayOther

    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.

Study groups in NCT01817192
Study groupRoleWhat they receive
ObservationActive comparatorPost-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.
Receives: Other: Radiographic surveillance; Other: 14-Gene Prognostic Assay
Adjuvant ChemotherapyActive comparatorAdjuvant 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.
Receives: Drug: Adjuvant Chemotherapy; Other: 14-Gene Prognostic Assay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival

    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.

    Measured: 5 years

Secondary outcomes (1)

  1. Overall Survival

    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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2013 (estimated)
  2. Study start11 Sep 2020
  3. Primary completion15 May 2027 (estimated)
  4. Study completion15 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01817192
Sponsor's protocol ID
EC-120888
Other IDs
IFCT-2002
Status last verified
Sep 2026
First submitted
16 Mar 2013
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kratz JR, He J, Van Den Eeden SK, Zhu ZH, Gao W, Pham PT, Mulvihill MS, Ziaei F, Zhang H, Su B, Zhi X, Quesenberry CP, Habel LA, Deng Q, Wang Z, Zhou J, Li H, Huang MC, Yeh CC, Segal MR, Ray MR, Jones KD, Raz DJ, Xu Z, Jahan TM, Berryman D, He B, Mann MJ, Jablons DM. A practical molecular assay to predict survival in resected non-squamous, non-small-cell lung cancer: development and international validation studies. Lancet. 2012 Mar 3;379(9818):823-32. doi: 10.1016/S0140-6736(11)61941-7. Epub 2012 Jan 27.

    PubMed 22285053

  • Woodard GA, Wang SX, Kratz JR, Zoon-Besselink CT, Chiang CY, Gubens MA, Jahan TM, Blakely CM, Jones KD, Mann MJ, Jablons DM. Adjuvant Chemotherapy Guided by Molecular Profiling and Improved Outcomes in Early Stage, Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Jan;19(1):58-64. doi: 10.1016/j.cllc.2017.05.015. Epub 2017 May 31.

    PubMed 28645632

  • Kratz JR, Van den Eeden SK, He J, Jablons DM, Mann MJ. A prognostic assay to identify patients at high risk of mortality despite small, node-negative lung tumors. JAMA. 2012 Oct 24;308(16):1629-31. doi: 10.1001/jama.2012.13551. No abstract available.

    PubMed 23093159

  • Spigel DR, Westeel V, Anderson IC, Greillier L, Guisier F, Bylicki O, Badin FB, Rousseau-Bussac G, Deldycke C, Griesinger F, Bograd A, Zhong W, Le Treut J, Van Hulst S, Gandara DR, Reck M, Hoffknecht P, Gubens MA, Crowley J, von der Leyen H, Woodard GA, Jablons DM, Kratz JR, Mann MJ; AIM-HIGH investigators. Adjuvant chemotherapy for stage IA-IIA non-squamous, non-small-cell lung cancer identified as molecular high-risk by a 14-gene expression profile (AIM-HIGH): an international, randomised, phase 3 trial. Lancet Respir Med. 2025 Oct;13(10):887-896. doi: 10.1016/S2213-2600(25)00213-9. Epub 2025 Jun 24.

    PubMed 40578381

Questions about this trial

What is this clinical trial studying?

A study testing Adjuvant Chemotherapy, Radiographic surveillance and 14-Gene Prognostic Assay in people with Non-Small Cell Lung Cancer, run by Razor Genomics at 49 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in France, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01817192, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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