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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT04291092
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18;
2. ECOG is 0-1;
3. Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
4. The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases;
5. According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
6. Sign informed consent and agree to collect the clinical efficacy and information of the patient.
Exclusion Criteria:
1. Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
2. Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
3. Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
4. Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
5. History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
6. Patients with interstitial lung disease or previous history of interstitial pneumonia;
7. Having a history of substance abuse and unable to abstain from it or having mental disorders;
8. who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
9. Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
10. previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;
11. (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
12. The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04291092
Study Brief:
Protocol Section:
NCT04291092