Non-small cell lung cancer
Conditions
Interventions
Study group:QL1706 (5mg/kg, iv, q3w) combined with chemotherapy as neo-adjuvant treatment for three cycles
Sponsors
Zhangzhou Municipal Hospital of Fujian Province
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old; 2.Histologically confirmed Stage II-III NSCLC (AJCC 8th edition); 3.ECOG Performance Status (PS) score of 0-1; 4.No EGFR/ALK gene mutations; 5.Patients must have at least one measurable lesion; 6.The tumor is expected to be completely resectable; 7.Patients have good pulmonary function to tolerate surgical treatment; 8.Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment; 9.Patients must fully understand the study and voluntarily sign an written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with unresectable locally advanced or metastatic disease; 2.Patients who have previously received any anti-tumor treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, immunotherapy, or any other experimental treatments; 3.Patients who are present with other cancers (other than NSCLC) within five years prior to the start of this trial; 4.Patients with unstable systemic diseases, such as uncontrolled hypertension or severe arrhythmias; 5.Patients with known or suspected active autoimmune diseases; 6.Patients are allergic to the investigational drug; 7.Patients with a history or current diagnosis of interstitial lung disease; 8.Patients with HIV infection; 9.Patients who have undergone major systemic surgery or suffered severe trauma within two months prior to the start of this trial; 10.Pregnant or breastfeeding women; 11.Patients with neurological or psychiatric disorders that prevent the compliance with the study; 12.Other situations deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Event-free survival;EFS rate at 24 months;Overall survival;Surgical outcomes;Adverse events; | — |
Countries
China
Contacts
Public ContactLin Yimin
Zhangzhou Municipal Hospital of Fujian Province
Outcome results
None listed