Lung cancer
Conditions
Interventions
test group:QL1706 (5 mg/kg, IV, d1, q3w) + chemotherapy (chemotherapy regimen to be determined by the investigator)
Sponsors
Nantong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18–75 years; 2. ECOG performance status 0–1; 3. Patients with recurrent or metastatic NSCLC diagnosed with EGFR mutations by histopathology and cytopathology; 4. Progression after second-line therapy; 5. At least one measurable target lesion according to RECIST 1.1 criteria; 6. Prior radiotherapy is permitted, but the area of radiotherapy must be = 12 weeks; 9. Patients with asymptomatic or stable central nervous system (CNS) metastases after treatment must meet the following criteria: (1) no radiographic progression for at least 4 weeks after treatment completion; (2) treatment completed at least 4 weeks prior to enrollment; (3) no systemic corticosteroid therapy (>10 mg/day of prednisone or equivalent dose) within 2 weeks prior to enrollment; 10. Organ function criteria must be met within 1 week prior to enrollment: (1) Blood count: white blood cell (WBC) count >= 3.0 × 10^9/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 100 × 10^9/L; Hemoglobin (HGB) >= 9.0 g/dL (2) Liver function: Aspartate aminotransferase (AST) = 30.0 g/L (3) Renal function: Serum creatinine = 50 mL/minute (using the Cockcroft/Gault formula) (4) Coagulation function: International normalized ratio (INR) 1.5 × ULN and there is no clinically or radiologically confirmed pancreatitis, the subject may be enrolled; amylase 1.5 × ULN and there is no clinically or radiologically confirmed pancreatitis, the subject may be enrolled. Alkaline phosphatase (ALP) = 50%; 11. Sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastases, but asymptomatic brain metastases are eligible for enrollment; 2. Patients with meningeal metastases; 3. Patients diagnosed with active autoimmune diseases (congenital or acquired), such as interstitial pneumonia (patients with complete remission of vitiligo are eligible for enrollment; patients with hypothyroidism who only require hormone replacement therapy may be re-enrolled; patients with type 1 diabetes are also eligible for enrollment); 4. Patients with a tendency to bleed, including acute gastrointestinal bleeding, persistent bleeding disorders, or coagulation disorders; 5. Patients with a history of allergy to any component of the study drug; 6. Non-surgically sterilized or fertile female patients must have a negative serum HCG test within 72 hours prior to the first dose, must not be breastfeeding, and must agree to use appropriate contraceptive measures (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months following the study treatment period; Male patients must agree to use appropriate contraceptive methods during the study treatment period and for three months following the completion of the study treatment period; 7. Patients currently participating in other interventional studies; 8. Other conditions deemed by the investigator to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Duration of relief;Disease control rate;Quality of Life Score; | — |
Countries
China
Contacts
Public ContactJianying Li
Nantong Cancer Hospital
Outcome results
None listed