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 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT06924606
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.
2. Patients with incurable locally advanced or metastatic or recurrent NSCLC who have experienced treatment failure with first-line treatment using a PD-1/PD-L1 inhibitor combined with platinum-based doublet chemotherapy (except docetaxel) or treatment failure with sequential first-line treatment using a PD-1/PD-L1 inhibitor and platinum-based doublet chemotherapy (except docetaxel) may be eligible. Previous treatments include anti-VEGF monoclonal antibody. For patients with operable early stage or locally advanced NSCLC who have received adjuvant and/or neoadjuvant therapy, radical radiotherapy or radiochemotherapy, disease progression or recurrence within 6 months after the last anti-tumor therapy, adjuvant/neoadjuvant/radiochemotherapy is considered as first-line therapy.
3. Subjects must have at least one measurable lesion according to RECIST v1.1.
Exclusion Criteria:
1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) component.
2. Sensitivity mutation of EGFR or ALK fusion; known ROS1 fusion, BRAF V600E mutation, MET 14 exon skip mutation, RET fusion, etc. Gene mutation. The EGFR and ALK fusion status must be tested in patients with non-squamous cell carcinoma (the mutation status must be confirmed based on the tissue test if the blood test is negative); the genetic test is not mandatory for patients with squamous cell carcinoma.
3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06924606
Study Brief:
Protocol Section:
NCT06924606