Squamous Non-small cell lung cancer
Conditions
Interventions
Routine dose group:Routine dose group: Every three weeks as a cycle. On the first day of each cycle, Gemcitabine 1000mg / m^2, Cisplatin 75mg / m^2, Carboplatin auc5 were injected intravenously, and G
Low dose group:Low dose group: Every three weeks as a cycle. Gemcitabine 750mg / m^2, Cisplatin 56mg / m^2 or Carboplatin auc3 were injected intravenously on the first day of each cycle 75. On the eig
Sponsors
Quzhou People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent before implementing any test related process; 2.Age >= 18 years old and 3 months; 11.For adequate organ function, the subjects shall meet the following laboratory indexes: 1) the absolute value of neutrophils (ANC) >= 1.5 x 10^9/L without granulocyte colony stimulating factor in recent 14 days; 2) Platelets >= 100 without blood transfusion in recent 14 days x 10^9/L 3) Hemoglobin > 9g / dL without blood transfusion or erythropoietin in recent 14 days; 4) Total bilirubin = 60 mL / min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme spectrum is within the normal range (for example, simple lab
Exclusion criteria
Exclusion criteria: 1.Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC. 2.Received radiotherapy before administration of the first study drug, Meet one of the following conditions: 1) more than 30% of bone marrow had received radiotherapy within 14 days before treatment; 2) received radiotherapy for lung lesions within 6 weeks before treatment and the dose was > 30Gy (the enrolled subjects must recover from the toxicity of previous radiotherapy to grade 1 or below, do not need glucocorticoid treatment and have no history of radiation pneumonia) 3) The end time of palliative radiotherapy was within 7 days before the administration of the first study drug. 3.Other malignant diseases other than NSCLC diagnosed within 5 years before the first administration (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection of carcinoma in situ). 4.Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration. 5.Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137). 6.Received systemic treatment with Chinese patent medicine with anti NSCLC indications or drugs with immunomodulatory effect (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration. 7.Active autoimmune diseases requiring systemic treatment (such as the use of disease relief drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment. 8.Being treated with systemic glucocorticoids (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: it is allowed to use glucocorticoids in physiological doses (<= 10 mg / day prednisone or equivalent). 9.There is clinically uncontrollable pleural effusion / peritoneal effusion (subjects who do not need to drain effusion or stop drainage for 3 days and have no significant increase in effusion can be enrolled). 10.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 11.Those who are known to be allergic to active ingredients or excipients such as cindilimab, pemetrexed, gemcitabine, carboplatin and cisplatin. 12.Not fully recovered from toxicity and / or complications caused by any intervention before starting treatment (i.e. <= grade 1 or reaching baseline, excluding fatigue or hair loss). 13.Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive). 14.Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number at the same time was higher than the upper limit of normal value in the laboratory of the research center). Note: hepatitis B patients who met the following criteria can also be admitted into the group: 1) HBV viral load <1000 copy /ml (200 IU/ml) before the first dose, the subjects should receive anti HBV therapy to avoid reactivation of the virus during the whole course of ch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective response rate (ORR) of treatment was evaluated according to RECIST (v1.1).;Assess the subject's progression free survival (PFS) according to RECIST (v1.1).;Assess the subject's disease control rate (DCR) according to RECIST (v1.1).;The duration of remission (DOR) was assessed according to RECIST (v1.1).;The overall survival (OS) of the subjects was evaluated according to RECIST (v1.1).; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of all adverse events (AE) was evaluated according to NCI CTCAE (V5.0);The incidence of adverse events (teaes) during treatment was evaluated according to NCI CTCAE (V5.0);The incidence of serious adverse events (SAE) was assessed according to NCI CTCAE (V5.0);The incidence of serious adverse events immune related adverse events (iraes) was evaluated according to NCI CTCAE (V5.0);Proportion of subjects who stopped treatment due to the above adverse events; | — |
Countries
China
Contacts
Public ContactJin Xuru
Outcome results
None listed