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)
Running, not enrolling · Not applicable
Conditions studied: Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT01817192
- Run by
- Razor Genomics
- People needed
- 420
- Starts
- 2020-09-11
- Expected to finish
- 2027-05-15
- Last updated by the study team
- 2025-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Leonard Cancer Institute — Mission Viejo, California, United States
- UC Davis Comprehensive Cancer Center — Sacramento, California, United States
- Providence Medical Foundation Santa Rosa — Santa Rosa, California, United States
- Sarah Cannon- FCS South — Fort Meyers, Florida, United States
- Sarah Cannon- FCS North — Petersburg, Florida, United States
- Sarah Cannon- FCS Panhandle — Tallahassee, Florida, United States
- Sarah Cannon- FCS East — West Palm Beach, Florida, United States
- Baptist Health Lexington — Lexington, Kentucky, United States
- Baptist Health Louisville — Louisville, Kentucky, United States
- Mercy Hospital Joplin Missouri — Joplin, Missouri, United States
- Mercy Oncology Research St. Louis — St Louis, Missouri, United States
- Hackensack Meridian Health — Neptune City, New Jersey, United States
- Sarah Cannon- Messino Cancer Center — Asheville, North Carolina, United States
- Mercy Oncology Research Oklahoma City — Oklahoma City, Oklahoma, United States
- Allegheny Health Network Research Institute — Pittsburgh, Pennsylvania, United States
- St. Francis Cancer Center — Greenville, South Carolina, United States
- Sarah Cannon Tennessee Oncology — Nashville, Tennessee, United States
- Swedish Cancer Institute — Seattle, Washington, United States
- Polyclinique Bordeaux Nord — Bordeaux, Cedex, France
- Hôpital Charles Nicolle — Rouen, Cedex, France
- CHU d'Angers Service Pneumologie — Angers, France
- Centre Hospitalier de la Côte Basque — Bayonne, France
- CHRU Besançon- Hôpital J. MINJOZ — Besançon, France
- Hôpital APHP Ambroise Paré — Boulogne, France
- Hia Percy — Clamart, France
Full record on ClinicalTrials.gov
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