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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT01356368
Eligibility Criteria:
Inclusion Criteria:
1. Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV
2. Having adequate tissue sample to perform the markers testing
3. Age ≥ 18 years
4. No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable)
5. No other concurrent cancer treatment
6. Performance status of 0- 2 per ECOG scale (Appendix II)
7. Adequate laboratory values as follows as follows:
Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤ 1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal level Serum creatinine ≤ 1.5 X institutional upper normal level
8. Presence of measurable disease
Exclusion Criteria:
1. Prior systemic treatment for lung cancer
2. History of hypersensitivity to drugs used
3. Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer
4. Medical illness that puts the patient at significant risk per investigator's discretion
5. Uncontrolled CNS disease. Patients with CNS metastatic disease treated with radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after the treatment initiation without increase dose of steroids
6. Positive pregnancy test or refusal to use contraception during treatment. (Gynecology consultant for contraception)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01356368
Study Brief:
Protocol Section:
NCT01356368