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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT02179528
Eligibility Criteria:
Inclusion Criteria:
* Pathological diagnosis of small cell lung cancer
* Extensive stage according to American Veteran Staging System
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST )1.1
* Eastern Cooperative Oncology Group (ECOG) scores for performance status of 0 to 2
* Age≥18 years
* Adequate organ function
* Consent form according with Guideline for Good Clinical Practice of the International Conference on Harmonisation (ICH-GCP)guidelines
* The expected survival≥2 months
Exclusion Criteria:
* Pathological diagnosis of mixed small cell lung cancer
* Limited stage according to American Veteran Staging System
* Other preexisting or existing malignant tumors,not including non-melanoma skin cancer with effective treatment,cervical cancer in situ or tumor response has been 3 years which is considered cured by the investigator
* Known pre-existing interstitial lung disease
* Pre-existing or uncontrolled gastrointestinal disease which may affect drug absorption or worsen existing disease believed by the investigator
* Any other medical history or coexisting disease that may affect compliance of patients or the assessment of safety and effectiveness of the drug believed by the investigator
* Pregnant or lactating women
* Active phase of hepatitis B virus infection,Active phase of hepatitis C virus infection or known HIV carriers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02179528
Study Brief:
Protocol Section:
NCT02179528