Non-squamous non small cell lung cancer
Conditions
Interventions
single arm:camrelizumab plus chemotherapy
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All subjects should sign an informed consent form (ICF) before starting the study; 2. Aged >= 70 years, male or female; 3. ECOG PS 0-1; 4. Non-squamous NSCLC with histologically or cytologically proven locally advanced or metastatic (stage IIIB, IIIC, or IV) that is inoperable and cannot be treated with radical concurrent chemoradiotherapy, according to the International Association for the Study of Lung Cancer and the American Joint Committee on Classification of Cancer, 8th TNM staging of Lung Cancer; 5. No EGFR-sensitive mutation, ALK fusion, or ROS1 fusion was confirmed histologically or cytologically; 6. Subjects who have not previously received systemic chemotherapy for advanced/metastatic NSCLC (Chemotherapy as neo-adjuvant/adjuvant therapy or chemoradiotherapy is permitted, as long as the treatment has been completed at least 12 months before the diagnosis of advanced or metastatic disease); 7. The expected lifetime of patients should be >= 3 months; 8. At least one radiographically measurable lesions via CT or MRI, as per RECIST 1.1; 9. Patients with asymptomatic or treated stable brain metastases; 10. Male subjects agreed to use contraception for 24 weeks from the start of the first dose of the study drug to the last dose of the study drug; 11. Laboratory tests meet the following criteria (not treated within 14 days): (1) Blood routine examination: White blood cell (WBC) >= 3.5 x 10^9/L; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Hemoglobin (Hb) >= 90 g/L; Platelet (PLT) >= 100 x 10^9/L; (2) Liver function: aspartate aminotransferase (AST) = 30 g/L; Alkaline phosphatase (ALP) = 45 mL/min (using Cockcroft/Gault equation); (4) Coagulation function: international standardized ratio (INR) <= 1.5, activated partial thromboplastin time (APTT) <= 1.5 x ULN; If the subject is receiving anticoagulant therapy, as long as the INR/PT is within the prescribed range for anticoagulant medication, refer to the drug instructions.
Exclusion criteria
Exclusion criteria: 1. Previous therapy: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another T-cell receptor that stimulates or cooperatively inhibits (e.g., CTLA-4); 2. Histologic types other than non-squamous NSCLC were diagnosed by histopathology or cytopathology, including mixed carcinoma or NSCLC with small cell lung cancer components or neuroendocrine differentiation; 3. Use of systemic corticosteroids (prednisolone > 10 mg/day or an equivalent physiological dose of another corticosteroid) or immunosuppressive agents for any medical condition within 14 days prior to the first use of camrelizumab. In the absence of active autoimmune disease, allows patients to use include the nasal spray and inhaled or topical use of corticosteroids or physiological doses of systemic steroid hormones ( 10 mg/ day or equivalent dose of other corticosteroids; 4. Patients with active brain metastasis or meningeal metastasis; Patients with spinal cord compression that failed to be cured or relieved after surgery and/or radiotherapy, or with compression incomplete or total paralysis after treatment of previously diagnosed spinal cord compression; 5. Received a tumor vaccine within 28 days prior to the first dose, Chinese herbal medicine with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin, or immune cell therapy, except for topical use to control pleural effusion); 6. Subjects expected to require any other form of antitumor therapy for NSCLC (including maintenance therapy with other drugs, radiation therapy, and/or surgical resection) during the study period; 7. Non-thoracic radiotherapy > 30 Gy within 4 weeks before the first dose, chest radiotherapy > 30 Gy within 24 weeks before the first dose, or palliative radiotherapy 10 mg prednisone or an equivalent dose of other corticosteroids due to toxicity or complications. Palliative radiation therapy is allowed for symptom control, but it must be completed within 2 weeks before the first dose and no further radiation therapy is allowed. Radiation pneumonitis was not allowed; 8. Presence of uncontrollable third space effusion, such as massive pleural or ascites or pericardial effusion (patients who do not require drainage or who do not have a significant increase in effusion 3 days after drainage is stopped may be enrolled); 9. The presence of active autoimmune disease or immune deficiency, or a history of the above, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.) were not included. The following exception: subjects were in stable condition, do not need systemic immune inhibitors, such as type I diabetes mellitus, hypothyroidism only need hormone replacement therapy, or don't need systemic treatment of skin diseases (such as vitiligo, psoriasis, or hair loss), or subjects no external incentive not expected recurrence can participate in this study; 10. Subjects who received the live vaccine within 30 days prior to the initial study drug or were expected to receive the live vaccine during the study period; 11. Drug-induced pneumonia, radiation-induced pneumonia requiring st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Duration of Response;Disease Control Rate;Overall Survival;1 year rate of Overall Survival;safety;Quality of life improvement; | — |
Countries
China
Contacts
Public ContactLiu Jiwei
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed