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This study is a randomized, national multicenter clinical study ,which is designed to compare the efficacy of the safety and efficacy of treatment every 3 weeks or 6 weeks in (Non-small-cell-cell cancer, NSCLC) subjects without systematic treatment, who used Pembrolizumab after 6 cycles of combined chemotherapy, estimated with stable efficacy (CR, PR, and SSD) .
In this study, subjects will be randomly assigned to the following two groups according to a 1:1 ratio:
(A) Standard maintenance programme group, pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year; (B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;
Full description
This study is a randomized, national, multicenter clinical study aimed at non-small-cell lung cancer (NSCLC) subjects with PD-L1 ≥ 1% who have not previously received systematic treatment After comparing Pembrolizumab alone or Pembrolizumab combined with chemotherapy for 6 cycles, after the efficacy evaluation was stable (CR, PR, and SD), the safety and clinical efficacy of maintenance therapy every 3 weeks and every 6 weeks were compared. The eligible subjects in this study will be randomly assigned into the following two groups according to the 1: 1 ratio:
(A) Standard maintenance program group, namely Pembrolizumab 200mg, every 3 weeks, a total of 2 years of treatment, followed up for 1 year; (B) Modified maintenance program group, namely Pembrolizumab 200mg, every 6 weeks, a total of 2 years of treatment, followed up for 1 year;
During the course of the trial treatment, if the subject develops disease (the first PD), the researcher will decide whether to continue the medication according to the patient's situation and communicate with the patient, and decide whether to unblind according to the specific situation, as follows: After the first PD of the subject, the researcher decides whether to continue the treatment with the original regimen according to the disease state of the subject. At least 4 weeks later, the tumor is evaluated again. If the tumor progresses again (the second PD), the subject's study treatment ends and the follow-up period is entered; if there is no progress, the original regimen is continued. If the subjects decide to continue to use Pembrolizumab-related treatment after PD, they must meet the corresponding indicators of the enrollment and exclusion criteria of this study:
The primary end point of this study was to compare the incidence of treatment-related grade 3-5 adverse events between the standard maintenance group and the modified maintenance group. The secondary end point was descriptive analysis of progression-free survival and overall survival. Using RECIST 1.1 as the evaluation standard, the independent imaging evaluation committee (IRRC) conducted the evaluation. For the first time to evaluate PD, regardless of whether they continue to study treatment after progression, the date of the first PD evaluated by IRRC will be used for all statistical analysis containing progress information.
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Inclusion criteria
Volunteer for clinical research, fully understand, inform and sign informed consent forms (Informed Consent Form, ICF), willing to follow and be able to complete all trial procedures. 2. 18 to 75 years old (with critical values) when signing ICF. 3. Hemology diagnostics of phase IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy. 4. No known EGFR sensitivity mutations or ALK, ROS1 gene rearrangement; 5. Patients have never received systemic treatment throughout the body for phase IV NSCLC. 6. The end of non-systematic anti-tumor therapy is not only 2 weeks from the end of the study drug, and the treatment-related AE is restored to CTCAE 4.03 to level 1 (except for level 2 hair loss). 7. Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements. 8. Patients must provide the required tumor tissue for PD-L1 expression level determination, and PD-L1 is 1%. Note: Samples of tumor tissue fixed by Formalin within 6 months prior to the first study of the drug use are recommended. Paraffin encapsulated tumor specimens (preferred) or unstained newly cut continuous tissue slices (preferred anti-stripping slides). A relevant pathological report of the above specimen sits must also be provided. Freshly collected specimens, excision, hollow needle core biopsy, excision, cut, stamping or clamp biopsy are all within acceptable range (preferred newly acquired tissue). Needle-absorbing samples (i.e., samples that lack a complete tissue structure only provide cell suspension and/or cell smears), brush samples, cell precipitation samples from chest or celiac fluidares are not accepted. The organization sample requirements are detailed in the laboratory operating manual. 9. The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1. 10. After 6 cycles of combination chemotherapy with Pembrolizumab 200mg Q3W or Pembrolizumab 200mg Q3W immunotherapy, the efficacy was assessed as CR, PR, SD. 11. The expected lifetime is 12 weeks. 12. The main organ function sits well, i.e. meets the following criteria (no blood transfusion, albumin, recombinant human platelet production or csphylitosin (CSF) treatment within 14 days prior to the first drug use in this study): 13. Organ function is normal:
White blood cells s.0 x 109/L
Absolute Neutlyte Granucyte Count (ANC) s2.0 x 109/L
Platelet count: 100 x 109/L
Hemoglobin s 90 g/L
Creatine s 1.5 x ULN;
Total bilirubin s 1.5 x ULN (except Gilbert syndrome, total bilirubin 3.0 mg/dL);
AST (SGOT) is 2.5 x ULN, for patients with liver metastiars, s.5 x ULN;
ALT (SGPT) is 2.5 x ULN, for patients with liver metastasis, s.5 x ULN;
Alkaline phosphatase is 3 times the normal upper limit;
Clotting function: activated part of the clotting enzyme time (APTT) s1.5 x ULN, clotting enzyme raw time (PT) or international standardized ratio (INR) s1.5 x ULN;
Female patients must meet one of the following:
(1) menopause (defined as having no menstruation for at least 1 year and no other reason for confirmation other than menopause); (2) sterilization performed (removal of the ovaries and/or uterus); (3) Fertility, but must meet: Serum pregnancy tests must be negative within 7 days of randomization and agree to use 1% annual failure rate of contraception or to maintain abstinence (avoiding heterosexual intercourse) (at least 120 days after the signing of an informed consent form to the last time the drug was administered) (1% annual failure rate of contraceptive methods including bilateral tubal ligation, male sterilization, correct use of ovulation-suppressing hormones, release of intrauterine and intrauterine devices) and intrauterine devices. 12) Male patients must meet the requirement to consent to abstinence (avoiding heterosexual intercourse) or to take contraception, provided that when the partner is a woman of childbearing age or who is pregnant, male patients must maintain abstinence or use condom contraception to prevent exposure to the embryo during treatment and for at least 150 days after the end of administration of the drug. Regular abstinence (e.g. calendar days, ovulation periods, basic body temperature or late-stage contraception) and in vitro ejaculation are substandard methods of contraception.
Exclusion criteria
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216 participants in 2 patient groups
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Central trial contact
Fen Lan; Jiesen Zhou
Data sourced from clinicaltrials.gov
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