unresectable clinically stage IIIB (T1-2 N3 M0) and IIIIC non-small cell lung cancer (NSCLC)
Conditions
Interventions
treatment group:Toripalimab plus chemotherapy
The participants received Toripalimab in combination with platinum-based doublet neoadjuvant conversion therapy, with each 3-week period constituting one
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Have a full understanding of this study and sign the Informed Consent Form (ICF) voluntarily; 2.Aged 18 to 70 years old, regardless of gender; 3.Histologically confirmed unresectable Stage IIIB (T1-2 N3 M0) or Stage IIIC (T3/T4 N3 M0) non-small cell lung cancer (NSCLC) according to the 8th Edition of the AJCC Staging System, with no prior anti-tumor treatment; 4.Have measurable lesions in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 6.Adequate organ function:; 7.Women of childbearing potential must undergo a serum pregnancy test within 7 days prior to the first administration of study drug with a negative result. Both women of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last administration of study drug.
Exclusion criteria
Exclusion criteria: 1.Non-small cell lung cancer (NSCLC), large cell neuroendocrine carcinoma (LCNEC), and sarcomatoid carcinoma involving the superior sulcus (Pancoast tumors). 2.Participants with known EGFR-sensitive mutations or ALK translocations; and non-squamous cell carcinoma patients with unclear EGFR and ALK mutation status. 3.Within 4 weeks prior to signing the ICF, having received any other investigational drug treatment or participated in another interventional clinical study, excluding those in the follow-up phase. 4.Prior treatment with any immune checkpoint blockade therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or BTLA-targeted drugs. 5.History of non-infectious pneumonia requiring systemic steroid therapy within 1 year prior to the first dose, or current presence of interstitial lung disease (ILD); 6.Known allergy to the investigational drug or excipients; history of severe allergic reactions to any monoclonal antibody; or a history of allergy to carboplatin, paclitaxel, or pemetrexed. 7.Within 6 months prior to screening, cardiovascular diseases meeting any of the following criteria: (1) Congestive heart failure with cardiac function >= NYHA Class III; or left ventricular ejection fraction (LVEF) = 450 milliseconds for males or >= 470 milliseconds for females, or risk factors for torsades de pointes, such as clinically significant hypokalemia as judged by the investigator, family history of long QT syndrome, or familial history of arrhythmia (e.g., pre-excitation syndrome); (4) Poorly controlled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy; (5) Acute myocardial infarction, severe or unstable angina, or coronary or peripheral artery bypass surgery within 6 months prior to the first dose; (6) Clinically significant arrhythmias, including but not limited to complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, or PR interval > 250 milliseconds. 8.Participants who have experienced arterial/venous thrombotic or embolic events within 6 months prior to the first dose, such as stroke (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, etc., may be enrolled if the investigator assesses the condition as stable and suitable for clinical study participation. 9.Severe, uncontrolled concomitant conditions that may affect the study results, including malignant pleural effusion; subjects with severe infections occurring within 4 weeks prior to the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.; subjects with any active infection are excluded. 10.Presence of any clinically significant systemic condition that, in the investigator's judgment, requires treatment, including but not limited to thyroid disorders (patients with stable thyroid function on hormone replacement therapy may be enrolled), organ transplant recipients, history of psychiatric disorders, substance abuse, alcohol abuse, or drug use. 11.Known human immunodeficiency virus (HIV) infection, or patients with active hepatitis B or hepatitis C. Patients who are HBsAg-positive may participate in this study if their HBV DNA level is < 500 IU/mL or below the lower limit of detection at the study center. Patients wh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical Resection Rate;R0 Resection Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response;Overall Survival;Pathological Complete Response;Objective Response Rate;Disease Control Rate;Progress Free Survival;Safety (Adverse events); | — |
Countries
China
Contacts
Public ContactJian Hu
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed