Non small cell lung cancer
Conditions
Interventions
Experimental group:Apatinib plus toripalimab combined with chemotherapy
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participated in the study and agreed to sign written informed consent, with good compliance and cooperation in follow-up. 2. At the time of signing the informed consent form, they are at least 18 years old and of both sexes; (3) Histologically diagnosed non-small cell lung cancer; 4. At least one measurable lesion (the long diameter of the measurable lesion on spiral CT scan > =10mm or the short diameter of the enlarged lymph node > =15mm according to RECIST1.1 requirements); 5. No previous systemic treatment or local treatment; 6.TNM stage: IIB to IIIB, resectable or potentially resectable; 7.ECOG score of 0-1; 8. The lung function is within the normal range; 9. Adequate hematology and organ function, based on the following laboratory test results obtained within 14 days before starting study treatment (unless otherwise stated) : blood routine: (no blood transfusion, no G-CSF, no medication for correction within 14 days before screening) Hb > =90 g/L; Neutrophil count > =1.5×10^9/L; PLT > =100×10^9/L. Biochemical examination: (no albumin transfusion within 14 days). Appropriate liver function: ALT and AST 50mL/min (using the standard Cockcroft-Gault formula) : for women: CrCl= ((140-age) x weight (kg) x 0.85) /72 x serum creatinine (mg/dL) for men: CrCl= ((140-age) x weight (kg) x 1.00) /72 x serum creatinine (mg/dL); 10. Women of childbearing potential: agree to abstain from sex (heterosexual intercourse) or use a contraceptive method with an annual contraceptive failure rate of =12 months, no cause other than menopause identified), and had not undergone sterilization (removal of ovaries and/or uterus). "Examples of contraceptive methods with an annual contraceptive failure rate of < 1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that suppress ovulation, hormone-releasing intrauterine devices (Iuds), and copper-ring Iuds." The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily lifestyle. Periodic abstinence (e.g., calendar day, ovulatory period, symptomatic body temperature, or postovulatory methods) and ex vivo ejaculation are not acceptable methods of contraception. 11. Men: consent to abstain from sex (heterosexual intercourse) or use of contraception and to abstain from sperm donation, defined as follows: when the female partner is fertile, the male patient must abstain from sex during treatment and for 6 months after the last dose, or use condoms plus other methods of contraception such that the contraceptive failure rate is less than 1% per year. Male patients also had to agree not to donate sperm during the same period. When the female partner was pregnant, the male patient had to abstain from sex or use condoms during treatment and for 6 months after the last dose to prevent the fetus from being affected by the study. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred li
Exclusion criteria
Exclusion criteria: 1.Previously received any immunotherapy. 2.ECOG performance status >1; 3.Confirmed distant metastasis or pleural metastasis; 4.Presence of actionable driver gene mutations with corresponding targeted therapies available, including EGFR mutations, ALK fusion, ROS1 fusion, RET, NTRK, BRAF V600E, MET exon 14 skipping mutation, etc. 5.Pregnant (positive pregnancy test prior to medication) or breastfeeding women. 6.Known hypersensitivity or intolerance to recombinant human PD-1 monoclonal antibody drugs or any of their components (including excipients); 7.Underwent major surgery (except diagnostic biopsy) within 4 weeks prior to the first dose of study drug, or the surgical incision has not yet completely healed; 8.Clinically significant cardiovascular or cerebrovascular disease, including but not limited to: acute myocardial infarction, severe/unstable angina, cerebrovascular accident or transient ischemic attack, or congestive heart failure (New York Heart Association class >=2) within 6 months prior to enrollment; arrhythmias requiring antiarrhythmic medication (other than beta-blockers or digoxin); or a QTc interval >480 milliseconds (ms) on repeat electrocardiograms. 9.Hepatic or renal insufficiency, such as jaundice, ascites, and/or total bilirubin >3 × ULN; creatinine (24-hour) >3.5 g/24 h or renal failure requiring hemodialysis or peritoneal dialysis; and/or urinalysis showing urine protein >=++ or confirmed 24-hour urinary protein >1.0 g. 10.Presence of an ongoing active infection with grade >2 per CTCAE v5.0. 11.Active autoimmune disease within the past two years or a history of autoimmune disease; participants with active, known, or suspected autoimmune disorders that could impair major organ function or have required/may require systemic immunosuppressive therapy—including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome associated with thrombotic events, granulomatosis with polyangiitis (Wegener’s), Sjögren’s syndrome, Guillain–Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following are permitted: type 1 diabetes mellitus; hypothyroidism requiring only hormone replacement; skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia); or conditions not expected to recur without an external trigger. Replacement therapy (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment. 12.Have received, or are scheduled to receive, an organ transplant or an allogeneic bone marrow transplant. 13.Active tuberculosis (Mycobacterium tuberculosis) or any other active infection. 14.Known history of human immunodeficiency virus (HIV) infection. 15.Severe non-healing wound, ulcer, or fracture. 16.Substance abuse; or any medical, psychological, or social condition that could interfere with the study, make patient compliance unstable, or potentially jeopardize patient safety. 17.Unresolved toxicity >1 grade per CTCAE v5.0 due to any prior therapy/procedure (excluding alopecia, anemia, and hypothyroidism). 18.Patients with past or current objective evidence of severely impaired pulmonary function, such as a history of severe pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, or drug-related pneumonitis. 19.Another malignancy that is concurrent or was diagnose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathologic Response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Treatment-emergent adverse events;Disease control rate (DCR);Event-free survival (EFS);Overall survival (OS);Objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactHanping Wang;Xiaohui Xu
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed