Non-small-cell lung cancer
Conditions
Interventions
Experimental group:Treated with Otto combination antibody (5 mg/kg) plus docetaxel (60-75 mg/m2) every 3 weeks (Q3W)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form and voluntarily join this study; 2. Histological/cytopathological testing confirmed stage IIIB-IV non-small cell lung cancer (AJCC 9th); 3. Negative mutations in common lung cancer driver genes such as EGFR, ALK, and ROS1 in tissue or plasma gene testing; 4. Age > = 18 years old and =3 months); 6. ECOG score 0-2 points; 7. Estimated survival >=3 months; 8. First-line regardless of whether combined with radiotherapy; 9. The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before starting study treatment): (1) Routine blood examination must meet: absolute neutrophil count (ANC) >=1.5×10^9/L; Hemoglobin (HB) >=9g/dL; Platelets (PLT) >=100×10^9/L; Serum albumin (ALB) >=2.8 g/dL. (2) Biochemical tests must meet the following criteria: total bilirubin (TBIL) =50ml/min (Cockcroft-Gault formula) The investigator judged that the patient could be treated with ipalolitovolimab combined with docetaxel; 11. Female subjects of childbearing potential should have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug and be proven negative, and are willing to use an effective method of contraception during the trial period until 3 months after the last dose of aitol combination antibodies; For male subjects whose partner is a woman of childbearing age, an effective method of contraception should be used during the trial and for 3 months after the last dose of the Otto combination antibody.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or pregnant; 2. Those who have confirmed hypersensitivity to ipalolitovorelimab and/or its excipients; 3. Severe allergic reaction to other monoclonal antibodies; 4. Previous receipt of bispecific antibodies; 5. Have any active autoimmune disease or have a history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy); 6. Suffering from cachexia; 7. Patients with hypertension that cannot be well controlled by antihypertensive drugs (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 8. Patients with congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA>=104 copy number/mL or 2000 IU/mL), or hepatitis C (positive for hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method); 9. Subjects who are required to use corticosteroids (>10mg/day, prednisone efficacy dose) or other immunosuppressants for systemic treatment within 14 days prior to the first use of study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement at a dose of >10mg/day, prednisone efficacy dose are allowed (Note: Immunosuppressants are acceptable for short-term prophylactic administration in subjects who are expected to receive chemotherapy); 10. The patient has active infection, unexplained fever within 7 days before medication>=38.5°C, or baseline white blood cell count >15×10^9/L; 11. Patients with active bleeding; Patients with peptic ulcers, intestinal perforation, or intestinal obstruction; 12. Patients who are participating in clinical trials of other drugs; 13. Patients who have received other immune checkpoint inhibitor therapy at the same time; 14. Grade 3-4 immune-related AEs in first-line immunotherapy combined therapy leading to drug withdrawal; 15. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival ; | — |
Countries
China
Contacts
Public ContactPanwen Tian
West China Hospital, Sichuan University
Outcome results
None listed