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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT06001151
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically/cytologically stage IIIB, IIIC, IV non-squamous Non-Small Cell Lung Cancer (NSCLC)
* PD-L1 TPS\<1%
* Life expectancy more than 3 months
* Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion
* Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled)
* ECOG score 0-1
* Patients must have at least one measurable lesion according to RECIST 1.1
* Has adequate organ function
* Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing)
* Voluntarily sign a written informed consent form
Exclusion Criteria:
* Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer
* With active central nervous system (CNS) metastases confirmed by CT or MRI
* With other malignancy within 3 years before enrollment
* With severe infections within 4 weeks of the first dose of study treatment
* Women who are pregnant or lactating
* History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring hormone therapy
* History of myocarditis, cardiomyopathy, and malignant arrhythmia
* Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc.
* Risk of bleeding, major hemoptysis, or with history of coagulation dysfunction
* Active autoimmune diseases that require systematic treatment within 2 years before enrollment
* History of Human Immunodeficiency Virus (HIV)
* With active hepatitis B infection
* With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06001151
Study Brief:
Protocol Section:
NCT06001151