patients with stage IB-IIIA non-small cell lung cancer (NSCLC) after radical surgery.
Conditions
Interventions
Experimental group:Joint stage:
Ralafpur a: 30mg/kg, D1
Squamous cell carcinoma: Paclitaxel 175mg/m2 or albumin paclitaxel 260mg/m2+carboplatin AUC 5, D1
Non squamous cell carcinoma: pemetrexed 500 mg
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older (including 18 years); 2.Histopathologically confirmed non-small cell lung cancer, any histological type is acceptable; 3.Postoperative pathology confirmed as stage IB (tumor size >= 4 cm), II-IIIA according to the IASLC 9th edition; 4.No EGFR mutations and no ALK rearrangements; 5.The resection margins are microscopically confirmed to be free of tumor (R0); margin assessment includes the bronchial, venous, and arterial stumps, the peribronchial soft tissue, any peripheral edge adjacent to the tumor, or the margins of additional resected tissue; 6.Systematic complete mediastinal lymph node dissection or lobe-specific mediastinal lymph node dissection is recommended. At a minimum, the pathology and/or surgical report must include examination of at least two different mediastinal (N2) lymph node stations, one of which is the subcarinal lymph node (station 7), and the other being a lobe-specific station; 7.Any grossly normal-appearing lymph nodes must be biopsied or resected; there should be no extracapsular tumor extension in the resected mediastinal (N2) lymph nodes. Extracapsular tumor extension is allowed in resected N1 lymph nodes; 8.A surgically resected tumor sample must be available for PD-L1 immunohistochemistry (IHC) expression assessment; 9.No evidence of disease (NED) is confirmed by clinical examination and baseline imaging assessment, documented by contrast-enhanced chest/upper abdomen CT scan, brain CT/MRI, and clinical examination, all completed within 12 weeks prior to the first study treatment date; 10.No prior or planned neoadjuvant or adjuvant radiotherapy and/or neoadjuvant systemic therapy for the current malignancy is allowed; 11.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 12.Normal organ function within 10 days prior to the first dose; 13.Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective contraception during the study period and for 180 days after the last dose of study drug; 14.Subjects voluntarily participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with bilateral simultaneous multiple primary non-small cell lung cancer; 2.Patients who have received treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents; 3.Patients who have received live vaccines within 30 days prior to the first dose; 4.Patients who have received any other investigational drug therapy or participated in another interventional clinical study within 4 weeks prior to the first dose; 5.Patients with a known history of human immunodeficiency virus (HIV) infection (known HIV 1/2 antibody positive). Patients with active hepatitis B or active hepatitis C. Active hepatitis B is defined as known HBsAg positive with HBV DNA = 500 IU/ml or = 1000 copies/ml. Active hepatitis C is defined as known positive hepatitis C antibody with known quantitative HCV RNA results above the lower limit of detection of the assay. 6. Patients receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 3 days prior to the first dose. Use of physiologic doses of glucocorticoids (= 10 mg/day of prednisone or equivalent) is permitted. 7. Use of corticosteroids is permitted during the study for the management of immune-related adverse events (irAEs), as premedication for chemotherapy administration, or as premedication for allergic reactions to intravenous contrast agents. 8. History or presence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans, obliterative vasculitis), drug-induced pneumonitis, active pneumonitis on CT imaging, or objective evidence of severely impaired pulmonary function. 9. Subjects with active, known, or suspected autoimmune diseases. Subjects with stable conditions that do not require systemic immunosuppressive therapy are permitted to enroll, such as those with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin disorders requiring no systemic treatment (e.g., vitiligo, psoriasis, or alopecia). 10.Presence of other malignancies within = 5 years prior to the first study treatment, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical treatment, or ductal carcinoma in situ after radical treatment. 11.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 12.Occurrence of severe infection (CTCAE > Grade 2) within 4 weeks prior to the first study treatment, such as infection-related complications requiring treatment, bacteremia, severe pneumonia, etc.; presence of signs or symptoms of infection requiring oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use) within 2 weeks prior to the first dose. Subjects requiring systemic antibiotic use due to infection. 13. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to the first study treatment; arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral infarction), deep vein thrombosis, and pulmonary embolism, within 6 months prior to the first study treatment. 14.Lack of resolution of surgery- or chemotherapy-related toxicities (non-hematologic toxicities must have resolved to Grade 1), excluding alopecia, fatigue, neuropathy, and decreased appetite/nausea. 15.Pregnant or breastfeed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Disease-Free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (QoL) Assessment;Overall Survival;Disease-Free Survival;Safety; | — |
Countries
China
Contacts
Public ContactWu Weibing
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed