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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT02179567
Eligibility Criteria:
Inclusion Criteria:
* Age ≥70 years old
* Cytologically or histologically documented NSCLC
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
* World Health Organisation (WHO) performance status 0-2
* Non-frail patients according to Comprehensive Geriatric Assessment
* No prior chemotherapy
* Life expectancy of at least 12 weeks
* Serum bilirubin less than 1.5 times the upper normal limit
* Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases
* Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance \>60 ml/min
* Neutrophil count more than 1.5x 109 /L
* Platelet count more than 100x 109 /L
* Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.
Exclusion Criteria:
* Hemoptysis
* Central nervous system metastases
* Hemorrhagic diathesis or coagulopathy
* Anticoagulation therapy; regular use of aspirin (\>325 mg/d), nonsteroidal anti-inflammatory agents, or other agents known to inhibit platelet function
* Major surgery within 28 days before enrolment
* Clinically significant cardiovascular disease
* Medically uncontrolled hypertension
* Radiological evidence of tumors invading or abutting major blood vessels
* Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
* Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02179567
Study Brief:
Protocol Section:
NCT02179567