Non-small cell lung cancer
Conditions
Interventions
Group1:Cisplatin injection?Carboplatin Injection?Pemetrexed Injection?Paclitaxel injection
Group2:Cisplatin injection?Carboplatin Injection?Pemetrexed Injection?Paclitaxel injection
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years (inclusive) at the time of signing the informed consent, both male and female are eligible; 2. Histologically confirmed, previously untreated stage II-III NSCLC (AJCC 8th edition). cTNM staging can be confirmed by PET-CT or pathological biopsy. For suspected lesions indicated by imaging that may lead to changes in TNM staging, including but not limited to contralateral mediastinal lymph nodes and supraclavicular lymph nodes, pathological biopsy verification is strongly recommended; (1) Cohort 1: Stage II, IIIA, or IIIB (N2) NSCLC considered resectable as assessed by MDT; (2) Cohort 2: Stage III NSCLC considered inoperable as assessed by MDT; 3. According to the surgeon's assessment, the overall lung function can tolerate the planned lung resection surgery; 4. No accompanying EGFR sensitive mutations, ALK fusion, ROS1 fusion, or RET fusion; gene testing is not mandatory for squamous cell carcinoma patients. Local laboratory test reports are acceptable, but testing must be performed with well-validated methods approved by inter-laboratory quality control or the NMPA (if a blood test for mutations is negative, confirmation must be based on tissue sample testing); if no previous test report exists or previous reports do not meet requirements, samples must be provided for testing; 5. At least 3 unstained tumor tissue slides should be available for biomarker testing such as PD-L1. If obtaining compliant tumor tissue samples is not possible, enrollment may still be allowed after consultation with the sponsor; 6. According to RECIST v1.1 (solid tumor efficacy evaluation criteria v1.1), the subject must have at least one measurable lesion; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (Appendix 2); 8. Expected survival time >= 12 weeks; 9. Functions of major organs meet the following requirements (Note: no use of any blood components or hematopoietic growth factors within 14 days prior to screening); (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (2) Platelets >= 100 × 10^9/L; (3) Hemoglobin >= 90 g/L; (4) Total bilirubin = 60 mL/min (Cisplatin) or CrCL >= 50 mL/min (Carboplatin) (Cockcroft-Gault formula, Appendix 3); (7) Urine protein qualitative test =2, a 24-hour urine protein quantification must be performed and the 24-hour urine protein must be <1 g; (8) Activated partial thromboplastin time (aPTT) / prothrombin time (PTT) <= 1.5 × ULN, international normalized ratio (INR) <= 1.5 (use of a stable dose of anticoagulants such as low molecular weight heparin or warfarin is acceptable, and INR should be within the expected therapeutic range); 10. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must not be breastfeeding. Female participants of childbearing potential, and male participants who have sexual intercourse with partners of childbearing potential and are not surgically sterile, must agree to use one highly effective contraceptive method (Appendix 4) from signing the informed consent form (ICF) until at least 6 months after the last dose of the study treatment, and sperm donation is prohibited during this period; 11. Willingness to join this study, sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Associated disease conditions in the study include: (1) Histologically or cytologically confirmed neuroendocrine tumor components (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) and NSCLC involving the upper sulcus; (2) Tumors encasing major blood vessels or showing significant necrosis or cavitation, which the investigator believes could increase the risk of bleeding; (3) Clinically significant hemoptysis (=2.5 ml) or tumor bleeding from any cause within one month before the first use of the study drug. 2. Patients who have received any of the following treatments: (1) Previous systemic anti-tumor therapy for non-small cell lung cancer (including investigational drugs), such as chemotherapy or immune-mediated therapy (including but not limited to anti-PD-1, anti-PD-L1, anti-CTLA-4 treatments) and anti-angiogenic therapy (e.g., drugs targeting the VEGF pathway); (2) Previous thoracic radiotherapy; (3) Receipt of any investigational drug within 4 weeks or 5 half-lives (whichever is shorter) before the first use of the study drug; (4) Participation in another clinical study at the same time, unless it is an observational (non-interventional) study, or the subject is in the follow-up period of an interventional clinical study; (5) Systemic treatment with corticosteroids (more than 10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks before the first use of the study drug. Inhaled or local corticosteroids are allowed. Short-term corticosteroid use (e.g., before intravenous contrast) within 2 weeks before the first administration is permitted; (6) Use of anti-tumor traditional Chinese medicine within 1 week before the first administration of the study drug; (7) Use of immunomodulatory drugs (thymosin, interferon, interleukins, etc.) within 2 weeks or 5 half-lives (whichever is shorter) before the first administration, or subjects who need to continue these drugs during the study period; (8) Receipt of anti-tumor vaccines or live vaccines within 4 weeks before the first administration of the study drug; (9) Major surgery or serious trauma within 4 weeks before the first administration of the study drug; fine-needle biopsy or other minor surgery within 7 days before the first administration, excluding placement of vascular infusion devices; (10) Use of antiplatelet therapy or anticoagulant therapy for treatment purposes within 10 days before the first use of the study drug; 3. Expected prior antitumor treatment toxicities have not recovered to = Grade 3 allergy to antibody-based drugs; 5. Presence of significant bleeding tendency or a history of severe coagulation disorders, or occurrence of Grade 3 or higher bleeding events within 6 months prior to first dosing, or currently having >= Grade 2 bleeding or factors judged by the investigator to carry a high risk of bleeding (e.g., active gastrointestinal ulcer or esophageal varices); 6. Occurrence of gastrointestinal perforation, intra-abdominal fistula, or intra-abdominal abscess within 6 months prior to first dosing, or currently judged by the investigator to have high-risk factors for hollow organ perforation/fistula formation, such as t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR Rate;Safety and tolerability (Adverse Events (AEs), Laboratory tests, AEs related to surgery, etc.);Event-free survival (EFS);Disease control rate (DCR);Objective response rate (ORR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactHaiyan Tu
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed