An interventional study of 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; and B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up; in Non-small-lung-cell Cancer, NSCLC and Pembrolizumab, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2020-11-30.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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;
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 216 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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(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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pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year;
Drug: 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;
pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;
Drug: B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;
(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;
progression-free survival
Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause
Time frame: three years
objective response rate
Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases
Time frame: three years
OS:overall survival
The time from randomization to death due to any cause. For subjects who have been lost to follow-up before death, the time of the last follow-up is usually calculated as the time of death.
Time frame: three years
Duration of mitigation (DOR)
Refers to the event that the first evaluation of the tumor is CR or PR to the first evaluation of PD or death of any cause
Time frame: three years
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Carcinoma, Non-Small-Cell Lung→
Second Affiliated Hospital, School of Medicine, Zhejiang University