Lung Cancer
Conditions
Interventions
1:Carrelizumab + docetaxel
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent and join the study voluntarily; 2. Histological/cytopathological tests confirmed advanced non-small cell lung cancer; 3. The mutations of common lung cancer driver genes such as EGFR, ALK and ROS1 were negative by tissue or plasma gene tests; 4. Aged 18-75 years, male or female; 5. Disease progression after first-line PD-1/PD-L1 inhibitors combined with platinum-containing chemotherapy (CR/PR/SD) (PD-1/PD-L1 inhibitors were defined as Pembrolizumab, sintilimab, camrellizumab or tislelizumab); 6. ECOG score 0-1; 7. Expected survival >= 3 months; 8. With or without radiotherapy in the treatment of first-line radiotherapy; 9. Vital organ functions shall meet the following requirements (no blood components and cell growth factors shall be used within 2 weeks before the start of study therapy): (1) Routine blood tests shall meet the following requirements: absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Hemoglobin (HB) >= 9 g/dL; Platelet (PLT) >= 100 x 10^9/L; Serum albumin (ALB) >= 2.8 g/dL; (2) Biochemical examination must meet: total bilirubin (TBIL) = 50 mL/min (Cockcroft-Gault formula); Thyroid function is normal; 10. The investigators determined that the patients could receive camrelizumab in combination with docetaxel.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Confirmed allergy to camrelizumab and/or its excipients; 3. Severe allergic reaction to other monoclonal antibodies; 4. Have any active autoimmune disease or history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy); 5. Suffering from cachexia; 6. Have hypertension that is not well controlled by antihypertensive medications (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 7. Patients with congenital or acquired immune deficiency (such as HIV-infected persons), active hepatitis B (HBV-DNA >= 104 copy number/mL) or hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of analytical method); 8. Subjects requiring systemic treatment with corticosteroids (> 10 mg/day, therapeutic dose of prednisone) or other immunosuppressive agents within 14 days prior to the initial use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroid and prednisone therapeutic dose of adrenocortical hormone replacement at doses > 10 mg/day are permitted; 9. The patients had active infection, unexplained fever >= 38.5 degree C within 7 days prior to medication, or leukocyte count > 15 x 10^9/L at baseline; 10. Patients with active bleeding; Patients with digestive tract ulcer, intestinal perforation or intestinal obstruction; 11. Patients who are participating in clinical trials of other drugs; 12. Patients who were also treated with other immune checkpoint inhibitors; 13. Grade 3-4 immune-related AE in first-line immunotherapy resulted in drug withdrawal; 14. In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, Overall Survival;ORR, Objective Remission Rate; | — |
Countries
China
Contacts
Public ContactJin Zhou
Sichuan Cancer Hospital
Outcome results
None listed