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 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT04606303
Eligibility Criteria:
Inclusion Criteria:
* Sign the informed consent form before starting any trial related procedure.
* 18-80 years old, male or female.
* Non-small cell lung cancer confirmed by cytology or histology. Evaluation by the researchers to confirm resectable stage IIB, IIIA or resectable stage IIIB (CT3-4N2M0) NSCLC patients without any treatment before.
* If the pathological type is adenocarcinoma, genetic testing is required.
* Newly treated patients or patients with failure of traditional preoperative neoadjuvant chemotherapy can be enrolled;
* ECOG PS 0-1.
* Good cardiac function, left ventricular ejection fraction \>50%;
* Good respiratory function, able to tolerate radical resection of lung cancer;
* Bone marrow hematopoietic function is good, leukocyte\> 4×10\^9/l; Hemoglobin\> 10g/dl; Platelet \> 100×10\^9/l;
* Good renal function, glomerular filtration rate\>60 ml/min.
* Good liver function, Total bilirubin(TBIL)\<1.5ULN, AST\<2.5 ULN, ALT\<3ULN;
* There must be at least one evaluable focus judged according to recist1.1 standard.
Exclusion Criteria:
small cell lung cancer confirmed by cytology or histology. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
Advanced lung cancer, or unresectable lung cancer A patient who had received preoperative neoadjuvant radiotherapy for NSCLC. Patients who have a history of active autoimmune disease or potentially recurrent autoimmune disease.
Patients with active hepatitis Allergic to study drug (Toripalimab ,cisplatin, carboplatin, paclitaxel, gemcitabine and pemetrexed) components excipients.
Patients were given antibiotics within 2 weeks. The investigator considered that the subject's comordities or other conditions may affect the compliance with the protocol or are not suitable for participating in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04606303
Study Brief:
Protocol Section:
NCT04606303