Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer

December 20, 2023 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1050

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 Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49033
        • Recruiting
        • CHU d'Angers Service Pneumologie
        • Principal Investigator:
          • José HUREAUX, MD
      • Bayonne, France, 33077
        • Recruiting
        • Centre Hospitalier de la Cote Basque
        • Principal Investigator:
          • Sophie Schneider, MD
      • Besancon, France, 25000
        • Recruiting
        • CHRU Besançon- Hôpital J. MINJOZ
        • Principal Investigator:
          • Virginie Westeel, MD
      • Boulogne, France, 92104
        • Recruiting
        • Hôpital APHP Ambroise Paré
        • Principal Investigator:
          • Etienne Giroux Leprieur, MD
      • Clamart, France, 92141
        • Not yet recruiting
        • HIA Percy
        • Principal Investigator:
          • Hervé Le Floch, MD
      • Créteil, France, 94000
        • Recruiting
        • Centre Hospitalier Intercommunal de Créteil
        • Principal Investigator:
          • Gaelle Rousseau-Bussac, MD
      • La Roche-sur-yon, France, 85925
        • Recruiting
        • Centre Hospitalier Départemental Vendée
        • Principal Investigator:
          • Cyril GUIBERT, MD
      • Lyon, France, 69008
        • Recruiting
        • Hopital Prive Jean Mermoz
        • Principal Investigator:
          • Pierre Bombaron, MD
      • Marseille, France, 13291
        • Recruiting
        • Hôpital Européen
        • Principal Investigator:
          • Jacques Le Treut, MD
      • Marseille, France, 13915
        • Recruiting
        • Hôpital Nord
        • Principal Investigator:
          • Laurent Greillier, MD
      • Mulhouse, France, 680100
        • Recruiting
        • Groupe Hospitalier Région de Mulhouse Sud -Alsace
        • Principal Investigator:
          • Didier Debieuvre, MD
      • Nîmes, France, 30029
        • Recruiting
        • Centre Hospitalier Universitaire de Nīmes
        • Principal Investigator:
          • Sylvie Van Hulst, MD
      • Paris, France, 75014
        • Recruiting
        • Hôpital Cochin
        • Principal Investigator:
          • Marie Wislez, MD
      • Paris, France, 75020
        • Recruiting
        • Hopital Tenon
        • Principal Investigator:
          • Jacques Cadranel, MD
      • Paris, France, 75877
        • Recruiting
        • Hopital Bichat
        • Principal Investigator:
          • Gérard Zalcman, MD
      • Paris, France, 75674
        • Recruiting
        • Hopital Paris Saint Joseph
        • Principal Investigator:
          • Stéphane Jouveshomme, MD
      • Pessac, France, 33604
        • Recruiting
        • Hôpital Haut-Lévèque (Bordeaux - CHU)
        • Principal Investigator:
          • Maeva ZYSMAN, MD
      • Poitiers, France, 86021
        • Recruiting
        • Chu de Poitiers
        • Principal Investigator:
          • Clotilde Deldycke, MD
      • Toulouse, France, 31059
        • Recruiting
        • Hôpital Larrey
        • Principal Investigator:
          • Julien Mazieres, MD
      • Tours, France, 37044
        • Recruiting
        • CHRU de Tours
        • Principal Investigator:
          • Antoine Legras, MD
      • Villejuif, France, 94805
        • Not yet recruiting
        • Gustave Roussy
        • Principal Investigator:
          • Benjamin Besse, MD
    • Cedex
      • Bordeaux, Cedex, France
        • Recruiting
        • Polyclinique Bordeaux Nord
        • Principal Investigator:
          • Sigolène Galland-Girodet, MD
      • Rouen, Cedex, France, 76031
        • Recruiting
        • Hopital Charles Nicolle
        • Principal Investigator:
          • Florian Guisier, MD
    • Cedex 9
      • Toulon, Cedex 9, France, 83800
        • Recruiting
        • Toulon HIA Sainte Anne-
        • Principal Investigator:
          • Olivier Bylicki, MD
  • Germany
      • Essen, Germany, 45239
        • Withdrawn
        • Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -
      • Gauting, Germany, 82131
        • Recruiting
        • München-Gauting
        • Principal Investigator:
          • Niels Reinmuth, MD
        • Principal Investigator:
          • Thomas Dell, MD
      • Georgsmarienhütte, Germany
        • Recruiting
        • Niels-Stensen-Kliniken
        • Contact:
          • Nicole Weimer
        • Principal Investigator:
          • Petra Hoffknecht, MD
      • Grosshansdorf, Germany, 22927
        • Recruiting
        • Lung Clinic Grosshansdorf-Department of Thoracic Oncology
        • Principal Investigator:
          • Martin Reck, MD
      • Köln, Germany, 51109
        • Recruiting
        • Köln-Merheim
        • Principal Investigator:
          • Eva L Buchmeier, MD
      • Oldenburg, Germany
        • Recruiting
        • Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg
        • Principal Investigator:
          • Frank Griesinger, MD
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Withdrawn
        • Highlands Oncology Group
    • California
      • Mission Viejo, California, United States, 92961
        • Active, not recruiting
        • Leonard Cancer Institute
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • David R. Gandara, MD
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation Santa Rosa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ian Anderson, MD
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Recruiting
        • Sarah Cannon- FCS South
        • Contact:
        • Principal Investigator:
          • Ivor Percent, MD
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • Sarah Cannon- FCS North
        • Contact:
        • Principal Investigator:
          • Vijay Patel, MD
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Sarah Cannon- FCS Panhandle
        • Contact:
        • Principal Investigator:
          • Jeffrey Bubis, MD
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Sarah Cannon- FCS East
        • Contact:
        • Principal Investigator:
          • Shachar Peles, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
        • Contact:
        • Principal Investigator:
          • Firas Badin, MD
        • Sub-Investigator:
          • Amy Schell, MD
        • Sub-Investigator:
          • Lee Hicks, MD
        • Sub-Investigator:
          • Arvinda Padmanabhan, MD
        • Contact:
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Health Louisville
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wangjian Zhong, MD, PhD
        • Sub-Investigator:
          • Leela Bhupalam, MD
        • Sub-Investigator:
          • James Code, MD
        • Sub-Investigator:
          • Khalid Ghosheh, MD
        • Sub-Investigator:
          • Andrew Hart, MD
        • Sub-Investigator:
          • John Huber, MD
      • Paducah, Kentucky, United States, 42003
        • Withdrawn
        • Baptist Health Paducah
    • Missouri
      • Joplin, Missouri, United States, 65804
        • Active, not recruiting
        • Mercy Hospital Joplin Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Oncology Research St. Louis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bethany Sleckman, MD
        • Sub-Investigator:
          • Hsiao-Ou Hu, MD
        • Sub-Investigator:
          • John Finnie, MD
        • Sub-Investigator:
          • Heide Rodgers, MD
        • Sub-Investigator:
          • Somasekhar Bandi, MD
        • Sub-Investigator:
          • Kavitha Kosuri, DO
      • Saint Louis, Missouri, United States, 63128
        • Withdrawn
        • Mercy Hospital South
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Recruiting
        • Hackensack Meridian Health
        • Contact:
          • Denise M. Theiler, MSN,RN,CHPN,OCN
          • Phone Number: 732-897-2871
        • Principal Investigator:
          • Thomas BAUER, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Sarah Cannon- Messino Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Chay, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Active, not recruiting
        • Mercy Oncology Research Oklahoma City
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network Research Institute
        • Contact:
        • Principal Investigator:
          • Benny Weksler, MD
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • St. Francis Cancer Center
        • Contact:
        • Principal Investigator:
          • Xeuzhong Yang, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Tennessee Oncology
        • Contact:
        • Principal Investigator:
          • David Spigel, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adam J Bograd, MD
        • Sub-Investigator:
          • Eric Vallieres, MD
        • Sub-Investigator:
          • Brian Louie, MD
        • Sub-Investigator:
          • Alex Farivar, MD
        • Sub-Investigator:
          • Ralph Aye, MD

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

Completely healed incisions

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, 2024

Study Completion (Estimated)

May 15, 2025

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 (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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