Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Razor Genomics
With
Encore Clinical
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
