Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Monotherapy Group: COPD patients with GOLD grade 3 who meet the inclusion criteria will receive adebrelimab 20 mg/kg by intravenous infusion every 3 weeks (Q3W), continued until dis
Experimental group:Combination Therapy Group: COPD patients with GOLD grade 1-2 who meet the inclusion criteria will receive treatment as follows:
- Non-squamous cell carcinoma patients: adebrelimab 2
- Squamous cell carcinoma patients: adebrelimab 20 mg/kg Q3W combined with carboplatin AUC 5.0/cisplatin plus albumin-bound paclitaxel (100 mg/m2 on Day 1, 8, 15 or 260 mg/m2 on Day 1) by intravenous
Sponsors
inling Hospital, Affiliated Hospital of Medical School, Nanjing University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all the following inclusion criteria to be enrolled in this study: 1. Patients who voluntarily participate in the study, sign and date the informed consent form, have good compliance, and cooperate with the follow-up; 2. ECOG score of 0-1; 3. 18 years old 12 months). 7. Patients with chronic obstructive pulmonary disease (COPD) who meet the COPD-related diagnostic criteria specified in the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (Revised Edition 2021) formulated by the Respiratory Branch of the Chinese Medical Association and the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2025 Report) (GOLD 2025), with stable condition for >= 2 weeks (stable phase patients). 8. Imaging evaluation (computed tomography [CT] or magnetic resonance imaging [MRI]) shows at least one measurable target lesion (according to Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1). 9. Asymptomatic or treated stable brain metastasis patients can be included, with laboratory indicators meeting the study protocol requirements. 10. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours before the first dose. Women of childbearing potential and male subjects with a female partner of childbearing potential must agree to use highly effective methods of contraception and avoid breastfeeding during the study and for 90 days after the last dose of study drug. After consultation with the subject, the investigator or his/her designee should confirm that the subject knows how to correctly and continuously use contraceptive methods. 11. Function of important organs meets the following requirements: (1) Blood routine: White blood cell (WBC) count >= 3.0 × 10^9/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet (PLT) count >= 100 × 10^9/L; hemoglobin (HGB) >= 9.0 g/dL (without corresponding supportive treatments such as blood transfusion or leukocyte elevation within 7 days). (2) Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30 g/L; alkaline phosphatase (ALP) = 50 mL/min (calculated by the Cockcroft/Gault formula); urinary protein (UPRO) < (++), or 24-hour uri
Exclusion criteria
Exclusion criteria: 1. Patients who have received any prior anti-tumor therapy, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine for anti-tumor therapy; 2. Patients with clinically symptomatic central nervous system metastases (e.g., brain, spinal cord) or leptomeningeal metastases; 3. Patients who received radiotherapy to the chest and whole brain prior to the first dose of study treatment (palliative radiotherapy for bone lesions completed before the first dose of study drug is permitted for enrollment); 4. Patients with a history of asthma or other respiratory diseases (bronchiectasis, pulmonary tuberculosis, interstitial pneumonia, occupational lung disease, sarcoidosis, etc.) and with objective evidence of radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function; 5. Significant contraindications to spirometry (history of myocardial infarction, cerebral or aortic aneurysm, ocular surgery, hemoptysis); 6. Patients with any active autoimmune diseases or history of autoimmune diseases (e.g., uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (patients may be included after hormone replacement therapy), pulmonary tuberculosis); patients with childhood asthma that has been in complete response (CR) and does not require any intervention after adulthood may be included, patients with skin diseases that do not require systemic therapies (e.g., vitiligo, psoriasis, or alopecia) may be included, and patients who require medical intervention with bronchodilators may not be included; 7. Diagnosis of immunodeficiency, or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. Use of physiological doses of glucocorticoids (=++ at baseline, or vasculitis, regardless of severity; 10. Major surgical treatment or significant traumatic injury within 28 days prior to the first dose; 11. Subjects who have received treatment with anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month prior to the first dose; 12. Received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent form (ICF); 13. Subjects with a prior or concurrent malignancy requiring active treatment within 5 years (excluding adequately treated malignancies with an expected 5-year survival rate >90%, such as basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, localized prostate cancer after radical surgery, localized bladder cancer, ductal carcinoma in situ after radical surgery, and breast carcinoma in situ); 14. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, hematopoietic systems, or other severe organ dysfunctions; 15. History
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival,(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate, ORR;Disease control rate, DCR;Disease Control Rate,DCR;Adverse Event,AE;Rate of acute exacerbations of COPD (per patient-year); | — |
Countries
China
Contacts
Public ContactTangfeng Lv
Department of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Outcome results
None listed