Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Intervention group:QL1706 5 mg/kg IV on Day 1 plus bevacizumab 7.5 mg/kg IV on Day 1, repeated every 3 weeks (Q3W). Therapy will continue until disease progression, unacceptable toxicity, participant
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
70 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. patients with histological biopsy-confirmed non-small cell lung cancer. 2. No detectable EGFR mutation (L858R or exon 19 mutation) or ALK fusion gene. 3. No prior systemic therapy for advanced, recurrent or metastatic NSCLC. 4. life expectancy >= 8 weeks. 5. Unsuitable for any platinum-based two-agent chemotherapy regimen due to poor baseline status (ECOG score of 2, or ECOG score of 0-1, age =70 years with severe comorbidities or contraindications to any platinum-based two-agent chemotherapy regimen). 6. formalin-fixed paraffin-embedded tissue available during the course of the disease or at screening. 7. patients with asymptomatic CNS metastases after treatment who meet all of the following criteria: measurable disease outside the CNS; supratentorial metastases and cerebellar metastases only; no need for ongoing corticosteroid therapy for CNS disease; no stereotactic radiotherapy within 7 days or whole brain radiotherapy within 14 days prior to randomisation; no intermediate progression between completion of the CNS directed therapy and radiological screening studies without evidence of intermediate-term progression between them. 8. Subjects should have adequate bone marrow and hepatic and renal functional reserve: (1) White blood cell count >= 3.5 x 10^9/L, neutrophil count >= 1.5 x 10^9/L, platelets >= 80 x 10^9/L; and (2) AST <= 1.5 times the upper limit of normal, ALT <= 1.5 times the upper limit of normal, total bilirubin <= 1.5 times the upper limit of normal; and (3) Serum creatinine <= upper limit of normal, blood urea nitrogen <= upper limit of normal. 9. Participate in the study voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Age 1.5 mmol/L, or serum Ca > 12 mg/dL, or corrected Ca > ULN). 3. Active malignancy within 3 years (except adequately treated basal-cell or squamous-cell skin cancer, superficial bladder cancer, or in-situ cervical, breast or localised prostate cancer). 4. Persistent >= grade-3 toxicity from prior therapy (NCI-CTCAE v5.0) that may interfere with study treatment. 5. Prior neoadjuvant/adjuvant chemo- or radiotherapy for non-metastatic disease unless completed = 6 months before randomisation. 6. Active autoimmune disease (exceptions: hypothyroidism, controlled type-1 diabetes). 7. Idiopathic pulmonary fibrosis, drug-related or active pneumonitis. 8. HIV-positive. 9. Active hepatitis B or C. 10. Active tuberculosis. 11. Severe infection within 4 weeks before randomisation. 12. Significant cardiovascular disease: NYHA class = II, MI, unstable angina or unstable arrhythmia within 3 months. 13. Major surgery within 4 weeks or expected need for major surgery during the study. 14. Prior allogeneic bone-marrow or solid-organ transplant. 15. Any condition that, in the investigator’s opinion, could compromise protocol compliance. 16. Investigational therapy within 28 days or participation in another therapeutic clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Overall Survival (OS);Disease control rate,DCR;Duration of Response (DOR); | — |
Countries
China
Contacts
Public ContactXiao Wenjing
The Affiliated Hospital of Qingdao University
Outcome results
None listed