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 9 July 2021
platelet count
metastasis
neutrophil count
cancer chemotherapy
adjuvant chemotherapy
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, nsclc
Treatment Adjuvant chemotherapy, Radiographic surveillance, 14-Gene Prognostic Assay
Clinical Study IdentifierNCT01817192
SponsorRazor Genomics
Last Modified on9 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
Age 18 years
Adequate tissue sample for the 14-Gene Prognostic Assay
Histologically documented completely resected (R0) Stage I or Stage IIA non-squamous NSCLC. Mixed histologies that include a squamous cell, small cell or neuroendocrine component are eligible for the study, as long as they contain at least some component that is neither squamous cell nor small cell nor neuroendocrine. Eligible resections include segmentectomy, lobectomy, bi-lobectomy, sleeve lobectomy, and pneumonectomy. Resections via wedge resection will not be eligible. Complete resection must also be accompanied by mediastinal lymph node sampling through mediastinoscopy, bronchoscopic sampling (e.g. endobronchial ultrasound guided biopsy) or surgical sampling. Nodes must be sampled from at least one of the following nodal stations: Levels 2, 4, 7, 8, 9 for right- sided cancer and levels 2,4,5,6,7,8 9 for left-sided cancers
Life expectancy excluding NSCLC diagnosis 5 years
ECOG performance status 0-1
Adequate haematological function
Absolute neutrophil count (ANC) 1500 cells/mm3 AND
Platelet count 100000 cells/mm3 AND
Haemoglobin 9 g/dL (may be transfused to maintain or exceed this level)
Adequate liver function
Total bilirubin < 1.5 x upper limit of normal (ULN) AND
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
Adequate renal function, with Serum creatinine 1.5 x ULN
Completely healed incisions

Exclusion Criteria

Final pathologic diagnosis of purse squamous cell histology, pure small cell or pure neuroendocrine histology, or any combination of only these three histologies
Evidence of greater than stage II A 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
Prior systemic chemotherapy or anti-cancer agent
Any pre- or post-operative radiotherapy
Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated CIS of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically, 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 any of the 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
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