Patients with pathologically or histologically confirmed advanced driver gene-negative NSCLC who have received first-line PD-1 monoclonal antibody combined with chemotherapy and have not progressed.
Conditions
Interventions
Non-lung squamous cell carcinoma group:PD-1 inhibitor combined with apatinib and chemotherapy
Lung squamous cell carcinoma group:PD-1 inhibitor combined with apatinib
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.The age of participants ranged from 18 to 70 years old when they signed the informed consent form. 2.Pathologically confirmed, unresectable, and ineligible for curative radiotherapy or chemotherapy, locally advanced (Stage III B/III C) or Stage IV non-small cell lung cancer (according to the 8th edition of the AICC); 3.At any time after initial diagnosis, EGFR mutations and ALK rearrangements were confirmed to be negative; 4.Participants had previously received first-line PD-1 monoclonal antibody combined with chemotherapy induction therapy without disease progression, with response evaluation of CR/PR/SD, and tolerated adverse reactions; 5.ECOG performance status: 0–1 points; 6.According to RECIST v1.1 criteria, the subject must have measurable target lesions confirmed by CT or MRI imaging. 7.Normal major organ function, with screening test results meeting the following requirements: 1) Blood routine examination standards must meet the following requirements (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulants for correction): A. Hemoglobin (Hb) = 90 g/L; B. Neutrophil count (ANC) >=1.5 × 10^9/L; C. Platelet count (PLT) >=100 × 10^9/L; 2) Biochemical tests must meet the following standards: A. Total bilirubin (TBIL) 60 ml/min (Cockcroft-Gault formula); D. Urinalysis results show urine protein (UPRO) < 2+ or 24-hour urine protein quantification < 1 g; 8.Male and female participants of reproductive age must agree to use adequate contraceptive measures throughout the study period and for 6 months after treatment. 9.Sign a written informed consent form, with good compliance expected with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Histologically or cytologically confirmed mixed-type NSCLC, including patients with squamous-adenocarcinoma mixed cancer and patients with NSCLC containing small cell lung cancer components; 2.Previous treatment with anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or checkpoint pathways), or any VEGF/VEGFR inhibitors; 3.Patients with active brain metastases (patients with stable symptoms following treatment for brain metastases may be eligible if the stable condition has been maintained for at least 4 weeks); 4.Imaging evidence of tumor cavities, tumor encasement, or invasion of major vessels. Additionally, the proximity of the tumor to major vessels should be considered. (Major vessels in the chest include the aorta, left pulmonary artery, right pulmonary artery, four pulmonary veins, superior vena cava, inferior vena cava, and aorta.); 5.Use of immunosuppressive drugs within 28 days prior to the first administration of PD-1 monoclonal antibodies, excluding nasal or inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., no more than 10 mg/day of prednisolone or equivalent physiological doses of other corticosteroids); 6.Systemic treatment with herbal medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) with antitumor indications within 28 weeks prior to the first dose; 7.Received a live attenuated vaccine within 30 days prior to the first dose or is expected to receive one during the study period; (For COVID-19 vaccine recipients, eligibility may be determined at the investigator's discretion); 8.Uncontrolled pleural effusion, pericardial effusion, or ascites, as determined by the investigator, or having undergone serous cavity drainage for therapeutic purposes within 4 weeks prior to treatment. 9.Subjects who have experienced severe infections within 1 month prior to enrollment, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; subjects with any active infections, or those who experienced unexplained fever >38.5°C during screening or prior to the first dose; 10.Participants with active autoimmune diseases or immunodeficiencies, or with a history of such conditions, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc., are excluded. Exceptions: Participants with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be eligible for the study. Patients with type 1 diabetes whose blood glucose is controlled through insulin administration may participate in this study. 11.Participants receiving systemic treatment with bronchodilators or other agents for asthma that is not adequately controlled are ineligible (those who achieved complete remission of asthma during childhood and require no intervention in adulthood may be included). 12.Participants with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the analytical method), or co-infection with hepatitis B and C; Note: HBV-infected subjects meeting the following criteria are also eligible for inclusion: HBV viral load must be <1000
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactZhijie Wang
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed