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 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT03986528
Eligibility Criteria:
Inclusion Criteria:
* A Histological or cytological confirmed diagnosis of Stage III-IV NSCLC, with no history of anticancer treatment including chemotherapy;
* Male or female aged 18-75years;
* Eastern Cooperative Oncology Group (ECOG) performance score 0-2;
* Life expectancy of at least 3 months;
* At least one radiographically measurable lesion per RECIST 1.1;
* Willing to join the clinic trail and sign informed consent;
* Able to comply with scheduled visits and treatments.
Exclusion Criteria:
* Presence of cerebral metastases;
* Confirmed positive for expression of expression of epidermal growth factor receptor (EGFR), activin receptor-like kinase (ALK), c-ros oncogene 1 (ROS1) mutation, or programmed death-ligand 1 (PD-L1)(tumor proportion score \[TPS≥ 50%\] in a genetic test;
* Participants with malignant pleural effusion underwent intrapleural injection chemotherapy;
* Current undergoing or preparing for treatment with target therapy;
* Current undergoing or preparing for radiotherapy to the thorax;
* Current undergoing or preparing treatment with tumor immunotherapy;
* Currently undergoing lipid-decreasing treament;
* Pregnant or breastfeeding woman;
* Fertile patients who are unwilling or unable to take effective contraceptive measures during the research period until 6 months after the study end later;
* A history of mental disorders；
* Severe and uncontrolled organic lesion or infection, including but not limited to cardiopulmonary failure and renal failure，which lead to poor tolerance of chemotherapy;
* Participated in other clinical trials of small molecule research drugs within 28 days prior to enrollment, or participated in other clinical trials of large molecule research drugs within 3 months before enrollment;
* Known allergy or intolerance to study medications;
* Considered to be otherwise unsuitable for the clinical study by researchers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03986528
Study Brief:
Protocol Section:
NCT03986528