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:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT03699033
Eligibility Criteria:
Inclusion Criteria:
* Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC).
* Stage IIIA subjects who are considered eligible for resection following neoadjuvant chemoradiation are eligible for this study.
* No PET/CT evidence of metastatic disease.
* An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons.
* If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible.
* Subjects must have measurable or evaluable disease.
* No prior thoracic radiotherapy.
* Age \> 18 years at time of registration.
* ECOG Performance Status of 0-2 (Karnofsky performance scale ≥ 60).
* Hgb \> 9 g/dL; ANC (absolute neutrophil count) \> 1500/µl; platelets \> 100,000 mcL.
* Subjects must sign study-specific informed consent form prior to registration.
* Radiation therapy and chemotherapy must start within 4 weeks of study enrollment.
Exclusion Criteria:
* Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
* Active connective tissue disorders, such as active lupus or scleroderma.
* Known Acquired Immune Deficiency (HIV (+)/AIDS).
* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regiment to harm nursing infants. Women of childbearing potential must agree to use medically approved and adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03699033
Study Brief:
Protocol Section:
NCT03699033