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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03195569
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥18 years and ≤75 years;
* Patients with histologically or cytologically confirmed inoperable locally advanced (Stage IIIb, not suitable for multidisciplinary treatment), metastatic (Stage IV), or relapsed non-squamous cell non-small cell lung cancer. Diagnostic result of non-squamous cell non-small cell lung cancer obtained based on sputum cytology should be immunohistochemically confirmed. If a variety of tumor ingredients are mixed, the main cell types should be classified;
* ECOG score of 0-1 points;
* At least one measurable lesion can be evaluated according to RECIST1.1 criteria;
* Patients who have not received systemic anti-tumor therapy of locally advanced or metastatic non-squamous non-small cell lung cancer (if the subject received adjuvant therapy after completing the radical treatment of early non-small cell lung cancer, but then the disease relapsed, the subject can be enrolled. In this case, the end time of the adjuvant therapy is required to be more than 6 months from the time of the first administration of this study, and various toxic reactions resulting from the adjuvant therapy should have recovered (≤ Grade 1 by CTCAE 4.03 criteria, except for alopecia);
* Expected survival time ≥24 weeks;
Exclusion Criteria:
* Central squamous cell carcinoma, and mixed gland squamous cell carcinoma with squamous cell as the main ingredient;
* ALK fusion gene is known to be positive;
* Medical history or examination shows thrombotic disease within 6 months prior to screening;
* Imaging shows signs of tumor invasion of large vessels, and the investigator or radiologist must exclude patients whose tumor has been completely close to or surrounded or invaded the lumen of large vessels (e.g., the superior pulmonary artery or superior vena cava);
* Patients with a past history of symptomatic brain metastases or meningeal metastases, or spinal cord compression;
* Patients who received palliative radiotherapy for bone lesions outside the chest within 2 weeks prior to the first dose of the study drug;
* Patients who received major surgical procedures (including thoracotomy), or suffered from major trauma (such as fractures) within 28 days
* prior to screening, or need to undergo major surgery during the expected study treatment period;
* Patients who received a minor surgical procedure within 48 hours prior to the first treatment with Anivitis® QL1101 (the investigator judges whether there is bleeding tendency);
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03195569
Study Brief:
Protocol Section:
NCT03195569