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Gene test may reveal which early lung cancers need chemo after surgery

NCT ID NCT01817192

Prevention Sponsor: Razor Genomics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether a 14-gene test can identify people with early-stage non-squamous non-small cell lung cancer who are at higher risk of the cancer returning after surgery. Patients whose tumors are completely removed and who test as intermediate or high risk are randomly assigned to either observation or four cycles of platinum-based chemotherapy. The trial compares disease-free survival between the two groups to see if the gene test can guide who should receive chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
platinum-based adjuvant chemotherapy
What this could lead to
If the gene test works, doctors could offer chemotherapy after surgery to the early-stage lung cancer patients most likely to benefit, while sparing others unnecessary treatment.
What could go wrong
The gene test may not reliably pick out who benefits, and chemotherapy carries risks of side effects. The trial may not show a clear advantage over observation alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

420 people

The number who actually took part.

Started

Sep 2020

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Allegheny Health Network Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baptist Health Louisville

    Louisville, Kentucky, 40207, United States

  • CHRU Besançon- Hôpital J. MINJOZ

    Besançon, 25000, France

  • CHRU de Tours

    Tours, 37044, France

  • CHU d'Angers Service Pneumologie

    Angers, 49033, France

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85925, France

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000, France

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029, France

  • Centre Hospitalier de la Côte Basque

    Bayonne, 33077, France

  • Chu de Poitiers

    Poitiers, 86021, France

  • Groupe Hospitalier Région de Mulhouse Sud -Alsace

    Mulhouse, 680100, France

  • Gustave Roussy

    Villejuif, 94805, France

  • Hackensack Meridian Health

    Neptune City, New Jersey, 07753, United States

  • Hia Percy

    Clamart, 92141, France

  • Hôpital APHP Ambroise Paré

    Boulogne, 92104, France

  • Hôpital Bichat

    Paris, 75877, France

  • Hôpital Charles Nicolle

    Rouen, Cedex, 76031, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Europeen

    Marseille, 13291, France

  • Hôpital Haut-Lévèque (Bordeaux - CHU)

    Pessac, 33604, France

  • Hôpital Larrey

    Toulouse, 31059, France

  • Hôpital Nord

    Marseille, 13915, France

  • Hôpital Paris Saint Joseph

    Paris, 75674, France

  • Hôpital Privé Jean Mermoz

    Lyon, 69008, France

  • Hôpital Tenon

    Paris, 75020, France

  • Köln-Merheim

    Cologne, 51109, Germany

  • Leonard Cancer Institute

    Mission Viejo, California, 92961, United States

  • Lung Clinic Grosshansdorf-Department of Thoracic Oncology

    Großhansdorf, 22927, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Mercy Hospital Joplin Missouri

    Joplin, Missouri, 65804, United States

  • Mercy Oncology Research Oklahoma City

    Oklahoma City, Oklahoma, 73120, United States

  • Mercy Oncology Research St. Louis

    St Louis, Missouri, 63141, United States

  • München-Gauting

    Gauting, 82131, Germany

  • Niels-Stensen-Kliniken

    Georgsmarienhütte, Germany

  • Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg

    Oldenburg, Germany

  • Polyclinique Bordeaux Nord

    Bordeaux, Cedex, France

  • Providence Medical Foundation Santa Rosa

    Santa Rosa, California, 95403, United States

  • Sarah Cannon Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon- FCS East

    West Palm Beach, Florida, 33401, United States

  • Sarah Cannon- FCS North

    Petersburg, Florida, 33705, United States

  • Sarah Cannon- FCS Panhandle

    Tallahassee, Florida, 32308, United States

  • Sarah Cannon- FCS South

    Fort Meyers, Florida, 33916, United States

  • Sarah Cannon- Messino Cancer Center

    Asheville, North Carolina, 28803, United States

  • St. Francis Cancer Center

    Greenville, South Carolina, 29607, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University Hospital of Munich

    München, 80336, Germany

  • University Medical Center Schleswig-Holstein

    Lübeck, Germany

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