Histologically confirmed stage IIIB-IV driver gene-negative NSCLC
Conditions
Interventions
Iparomlimab and Tuvonralimab (QL1706) group:Use of Iparomlimab and Tuvonralimab (QL1706)
Sponsors
Central Hospital of Guangdong Provincial Nongken
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=70 Years, Both Male And Female. 2. Histologically Confirmed Stage IIIB-IV NSCLC. 3. No Prior Systemic Therapy, Or Patients With Recurrence After Adjuvant Chemotherapy For Locally Advanced Postoperative Cases, Or Recurrence After Definitive Concurrent Or Sequential Chemoradiotherapy For Locally Advanced Disease. 4. Driver Gene-Negative (E.g., No Mutations In EGFR, ALK, ROS1, BRAF, RET, MET Exon 14 Skipping, Or NTRK). 5. At Least One Measurable Lesion As Defined By RECIST V1.1. 6. ECOG Performance Status Of 0-1. 7. Life Expectancy Of At Least 3 Months. 8. Adequate Organ Function, Meeting The Following Criteria (Without Transfusion Or Blood Products, And Without Use Of G-CSF Or Other Hematopoietic Growth Factors Within 14 Days): (1) Complete Blood Count (CBC): Hemoglobin (HGB) >=90 g/L; Platelets (PLT) >=100 ×10^9/L; Absolute Neutrophil Count (ANC) >=1.5 ×10^9/L; White Blood Cell Count (WBC) >=3.0 ×10^9/L. (2) Blood Biochemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), And Alkaline Phosphatase (ALP) =3 g/dL; Serum Creatinine =40 mL/min (Calculated Using The Cockcroft-Gault Formula). (3) Urinalysis: Urine Protein =2+, A 24-Hour Urine Protein Quantification Is Required; Subjects With 24-Hour Urine Protein =50%. 9. Men And Women Of Reproductive Potential Must Agree To Use Medically Approved Contraceptive Methods During The Study And For 6 Months After The Last Dose Of The Study Drug. 10. Voluntary Participation In This Study, With Signed Informed Consent Form (ICF), Good Compliance, And Willingness To Cooperate With Follow-Up.
Exclusion criteria
Exclusion criteria: 1. Prior Treatment With Immune Checkpoint Inhibitors, Immune Checkpoint Agonist Antibodies, Or Immune Cell Therapies. 2. Systemic Use Of Corticosteroids Or Other Immunosuppressive Medications Within 2 Weeks Prior To The First Dose. 3. Presence Of Other Concurrent Malignancies Prior To The First Dose. 4. Any Active Autoimmune Disease Or A History Of Autoimmune Disease. 5. Major Surgery Within 4 Weeks Prior To The First Dose, Or Unhealed Wounds. 6. Lung Radiation Therapy With A Dose >30 Gy Within 6 Months Prior To The First Dose. 7. Completion Of Palliative Local Therapy For Non-Central Nervous System (CNS) Lesions Within 7 Days Prior To The First Dose. 8. Vaccination With A Live Vaccine Within 30 Days Prior To The First Dose Of Study Treatment. 9. Known Or Screening-Detected Symptomatic Active Central Nervous System (CNS) Metastases. 10. Clinically Significant Cardiovascular Or Cerebrovascular Disease. 11. Systemic Infection Or Other Severe Infections Requiring Systemic Antibiotic Therapy Within 2 Weeks Prior To Enrollment; Or Unexplained Fever >38.0°C During The Screening Period Or Prior To Enrollment; Or Inability To Discontinue Aspirin Or Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) For More Than 5 Days. 12. Anticipated Need For Any Other Form Of Anti-Tumor Therapy During The Study Period. 13. Treatment With Traditional Chinese Medicine (TCM) With Anti-Tumor Indications (Requiring A Washout Period) Or Drugs With Immunomodulatory Effects Within 2 Weeks Prior To The First Dose. 14. Active Tuberculosis, Or A Diagnosis Of Tuberculosis With Anti-Tuberculosis Treatment Within 1 Year Prior To Screening. 15. Positive For Human Immunodeficiency Virus (HIV) Antibody; Positive For Syphilis Antibody; Uncontrolled Active Hepatitis B; Or Active Hepatitis C. 16. Clinically Significant Pulmonary Impairment, Including But Not Limited To A History Of Idiopathic Pulmonary Fibrosis, Drug-Induced Pneumonitis, Interstitial Lung Disease, Or Other Concurrent Pulmonary Diseases Causing Severe Pulmonary Impairment. 17. Symptomatic Third-Space Effusions Requiring Repeated Drainage, Such As Pericardial, Pleural, Or Ascitic Effusions That Cannot Be Controlled By Thoracentesis Or Other Treatments. 18. History Of Allogeneic Hematopoietic Stem Cell Transplantation Or Organ Transplantation. 19. Known History Of Hypersensitivity To Macromolecular Biological Products, Or To Any Component Of Iparomlimab And Tuvonralimab (QL1706) And Other Study Drugs; Or A History Of Severe Hypersensitivity To Chemotherapy Agents Such As Pemetrexed, Carboplatin, Or Their Prophylactic Medications. 20. Currently Participating In An Interventional Clinical Study, Or Having Received Any Other Investigational Drug Or Study Device Treatment Within 4 Weeks Prior To The First Dose. 21. Known History Of Psychotropic Substance Abuse, Alcoholism, Or Drug Addiction; Or A Clear History Of Neurological Or Psychiatric Disorders, Including Epilepsy Or Dementia. 22. Patients Who, In The Investigator's Judgment, May Have An Increased Risk Related To The Study, May Interfere With The Interpretation Of Study Results, Or Are Otherwise Considered Unsuitable For Enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival rate; | — |
Countries
China
Contacts
Public ContactCaiyong Guang
Central Hospital of Guangdong Provincial Nongken
Outcome results
None listed