NSCLC Clinical Trial
Official title:
A Similar Phase I Study on the Pharmacokinetics and Safety of Single-dose and Parallel Comparisons in Patients With Advanced NSCLC Treated With Recombinant Humanized Anti-PD-1 Monoclonal Antibody (JS001) Before and After Process Change
This study was designed to evaluate the similarity of single-dose and parallel comparisons of
recombinant humanized anti-PD-1 monoclonal antibody injections before and after process
changes. It is designed to be a single-center, open and parallel controlled phase I study.
Patients with advanced NSCLC will be enrolled.
After determining that the patient is qualified, the patient will be assigned to a batch of
drug use in the order in which they are selected. The dosage of drug was set at 3 mg / kg.
Planned to recruit subjects each 12 patients (24 cases) to participate in this study, taking
into account a 20% dropout rate, so that the total of 15 patients (30 patients) subjects in
each group in this study.
This study was divided into study phase (single-dose period) and follow-up stage
(multiple-dose period).Each subject first conducted a single dose safety and pharmacokinetics
(PK) study.If the subject did not develop adverse events that had significant clinical
significance as suggested by the investigators within 28 days of the single dose and
continued reorganization of the humanized anti-PD-1 monoclonal antibody injection to benefit
the patient , and with the agreement of subjects, the subject will enter the follow-up phase
(multiple-dose period). The same dose of recombinant humanized anti-PD-1 monoclonal antibody
injection was administered once every 2 weeks and 4 consecutive cycles of treatment for one
cycle of continuous period.Until the patient has developed tumor progression or an
untolerated toxic side effect, the patient voluntarily exits the study or believes that the
situation is not suitable for continuing treatment. There are follow-up of 90 days after
treatment.
n/a
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