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 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT05878028
Eligibility Criteria:
Inclusion Criteria:
* Non-small cell lung cancer patients diagnosed by pathological histology.
* Imaging examination showed stage IV disease.
* Non-squamous cancer patients shall be EGFR , ALK, ROS1, RET, MET negative.
* Failure from anti-PD-1 antibody treatment, including treatment ineffective or effective for a period then progress.
* The Eastern Oncology Collaboration Group (ECOG) scores 0-1.
* At least one imaging lesion can be measured, according to the standard for evaluating the effectiveness of solid tumors (RECIST 1.1).
* Asymptomatic or stable symptoms after local treatment is allowed.
* Subjects are allowed to receive palliative radiation.
* Enough organ functions well.
* Patients have good superficial venous blood circulation, which can meet the needs of intravenous dripping.
* No other serious diseases that conflict with this study regimes (e.g. autoimmune diseases, immune deficiencies, organ transplants, chronic infections).
* For female subjects with reproductive age, the pregnancy test should be accepted within 3 days prior to the first study drug administered (day 1 of cycle 1) and the results are negative.
* In the event of a risk of conceival, all subjects (male or female) must adopt contraception at a rate of less than 1% annually for the entire treatment period up to 120 days after the last study of the drug was administered (or 180 days after the last study of the drug).
* The patient himself agrees to participate in this clinical trial, sign the Informed Consent Letter, complete the procedure, treatment, and follow-up.
Exclusion Criteria:
* Small cell lung cancer (SCLC), including mixing pathology, combined with SCLC and NSCLC.
* Accepted radiation treatment in special organ before the first drug was administered, eg: more than 30% bone marrow within 14 days.
* Diagnosed with second malignant diseases within five years.
* Participating in other clinical trial.
* Treatment with other drugs, including thymus peptide, interferon, interleukin, and so on.
* Active autoimmune diseases requires systemic treatment.
* Receiving glucocorticoid therapy, excluding local glucocorticoids in nose, inhalation or other pathways, or any other form of immunosuppressive therapy.
* Uncontrolled chest and abdominal fluid.
* Patients have accepted organ transplantation or hematopoietic stem cell transplantation.
* Allergic to intervention drugs, including ingredients and auxiliary components. ·Incomplete recovery from the adverse events.
* Active hepatitis B or HCV infection.
* Accepted active vaccines within 30 days before the first dose.
* Women who are pregnant or breastfeeding.
* Symptomatic CNS metastasis.
* Uncontrolled active infections, eg. sepsis, mycemia, fungal hematoma.
* With serious mental disorders.
* Other conditions that the researchers believe in having potential risks which are not suitable for this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05878028
Study Brief:
Protocol Section:
NCT05878028