Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT01817192
Eligibility Criteria:
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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01817192
Study Brief:
Protocol Section:
NCT01817192