Lung cancer is the malignant tumor with the highest incidence and mortality in China.
Non-small cell lung cancer (NSCLC) ,which includes non-squamous cell carcinoma (including
adenocarcinoma, large cell carcinoma, and other cell types) and squamous cell carcinoma,
accounts for about 80% of lung cancer. Platinum-based two-drug chemotherapy is the first-line
standard treatment for driver-gene negative advanced NSCLC, but most patients experience
disease progression after 4 to 6 months. To extend the efficacy of first-line treatment,
maintenance therapy is a logical clinical option for patients who are effective after 4 to 6
cycles of standard treatment. There is currently no standard regimen for maintenance
treatment of NSCLC. We evaluated the effectiveness and safety of maintenance therapy with the
anti-PD-1 monoclonal antibody (Toripalimab injection) followed by the first-line standard
regimen in advanced NSCLC patients who are effective after standard treatment. With a view to
exploring treatment methods that are effective for the maintenance treatment of driver-gene
negative advanced NSCLC and have little toxic and side effects,thereby improving the survival
prognosis of these patients.
Platinum-based two-drug chemotherapy is the first-line standard treatment for driver-negative
advanced NSCLC, but most patients experience disease progression after 4 to 6 months. To
extend the efficacy of first-line treatment, maintenance therapy is a logical clinical option
for patients who are effective after 4 to 6 cycles of standard treatment. There is currently
no standard regimen for maintenance treatment of NSCLC. We evaluated the effectiveness and
safety of the anti-PD-1 monoclonal antibody (Toripalimab injection) followed by maintenance
therapy in advanced NSCLC that was effective in the first-line standard regimen.Thereby
improving the survival prognosis of advanced NSCLC.
- Fully understand the research and voluntarily sign the informed consent form (ICF)
- Age 18 to 75 years
- Histological or cytological documentation of non-small cell lung cance.
- Diagnosed as stage IV by imaging (staging according to AJCC eighth edition).
- Gene test is negative for EGFR, ALK, ROS1 confirmed by molecular pathology (tissue,
ARMS method or NGS).
- Previously received first-line standard chemotherapy for non-small cell lung cancer
(platinum combined with third-generation chemotherapy drugs in a two-drug combination
regimen: pemetrexed or paclitaxel or docetaxel or gemcitabine or vinorelbine combined
with cisplatin or carboplatin), and which were assessed the effectiveness by
imaging(SD, PR or CR).
- At least one measurable lesion according to Response Evaluation Criteria in Solid
Tumors (RECIST) criteria measured within 4 weeks prior to registration.
- ECOG performance status 0-1
- Expected overall survival time≥3 months
- Adequate bone marrow, Coagulation function，hepatic and renal function should be
assessed by the following laboratory requirements conducted within 7 days before
starting study treatment:
- Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet
count ≥ 100 x109/ L, hemoglobin (Hb) ≥9g/ dL.
- Total bilirubin ≤ 1.5 x the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN.
- Serum creatinine ≤ 1.5 x the ULN.
- Calculated creatinine clearance or 24 hour creatinine clearance ≥ 40 mL/ min.
- INR≤1.5, Activated partial thromboplastin time(APTT)≤1.5×ULN.
- Patients with hepatitis B virus (HBV) infection and inactive/asymptomatic HBV
carriers, or patients with chronic or active HBV, if the HBV DNA is <500IU/ml, or
2500copies/ml at the time of screening,can enter the group.
- Male subjects and women of childbearing age must have contraception within 24 weeks
from the start of the study to the last time of using the drug.
- Tumor histology or cytology pathology confirmed with small cell lung cancer components
or sarcomatoid lesions.
- Previously received any T-cell co-stimulation or immune checkpoint therapy, including
but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 / 2 inhibitors or other
drugs that target T cells.
- Major autoimmune diseases.
- Subjects who were vaccinated or planned to be vaccinated within 4 weeks before the
first time using the study drug.
- LD, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or
clinically active pneumonia or severe pulmonary dysfunction.
- TB or subjects with a history of active tuberculosis infection ≤ 48 weeks before
screening, whether or not treated.
- Symptomatic cardiac disease, such as: heart failure above NYHA level 2, unstable
angina pectoris, myocardial infarction occurred within 24 weeks, clinically
significant supraventricular or ventricular arrhythmias require treatment or
- Acquired immunosuppression (AIDS or major immunosuppressive agents)
- Suffering from active viral hepatitis. Defined as: Hepatitis B virus (HBV) infection
and HBV DNA ≥ 2500 copies / ml; or Hepatitis C virus (HCV) infection (quantitative
test results of anti-HCV positive and HCV RNA are greater than the lower limit of
- Mental illness, alcohol, drug or substance abuse
- Pregnant or lactating women.