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

  • STATUS
    Recruiting
  • End date
    May 15, 2025
  • participants needed
    1050
  • sponsor
    Razor Genomics
Updated on 24 July 2022
platelet count
metastasis
neutrophil count
cancer chemotherapy
adjuvant chemotherapy
platinum doublet
kidney function test
endobronchial ultrasound
lung carcinoma
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer

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 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.

Details
Condition Non-Small Cell Lung Cancer
Treatment Adjuvant chemotherapy, Radiographic surveillance, 14-Gene Prognostic Assay
Clinical Study IdentifierNCT01817192
SponsorRazor Genomics
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
Age ≥ 18 years
Adequate tissue sample for the 14-Gene Prognostic Assay
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)
ECOG performance status 0-1
Histologically documented completely resected (R0) Stage I or IIA non-squamous NSCLC (per
Willing to be randomized to chemotherapy
th edition, TNM staging system)
Life expectancy excluding NSCLC diagnosis ≥ 5 years
Completely healed incisions
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