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:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT06987734
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Patients have voluntarily to join the study and give written informed consent for the study.
3. Histologically documented, stage II-IIIA Non-Small Cell Lung Cancer (according to version 9th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated.
4. Tumor should be considered resectable before study entry by a multidisciplinary team.
5. ECOG Performance Status of 0 or 1
6. At least 1 unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
7. Able to comply with study and follow-up procedures
8. Major organ function For regular test results（no blood transfusion within 14 days）：
1. Hemoglobin（HB）≥90g/L；
2. Absolute neutrophils count（ANC）≥1.5×109/L；
3. Blood platelets（PLT）≥100×109/L
Biochemical tests results defined as follows:
1. Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ；
2. Alanine aminotransferase (ALT) and aspartate aminotransgerase AST≤2.5\*ULN,
3. Creatinine（Cr）≤1.5\*ULN or Creatinine Clearance rate (CCr)≥60 ml/min; Coagulation test: INR/APTT within normal limits Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value (50%).
9. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters
10. Subjects must provide fresh tissues or formalin-fixed tumor tissue samples at or the diagnosis NSCLC for mIF.
Exclusion Criteria:
* 1\) All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
2\) Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
3\) Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy 4) Severe acute or chronic infections, including: hepatits B, hepatits C, HIV etc 5) Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
6\) Histologically confirmed adenosquamous carcinoma 7) Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins 8) Subjects have interstitial lung disease (ILD), or a history of ILD that required corticosteroid treatment.
9\) Women in pregnancy or lactation. 10) Patients who are allergic to any of the agent or any ingredient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06987734
Study Brief:
Protocol Section:
NCT06987734