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PK Study for Endostar Continuous Intravenous Infusion in NSCLC Patients With 1st-line Platinum Based Chemotherapy

NCT04942301 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-06-30

No results posted yet for this study

Summary

This trial is an open-label, randomized, multicenter study to explore Endostar in combination with standard platinum-based chemotherapy with different methods in patients with advanced/metastatic non-small cell lung cancer (NSCLC)

Conditions

  • Advanced or Metastatic NSCLC

Interventions

DRUG

Endostar

This product combined with other combined chemotherapeutics is used to treat patients with stage III/IV NSCLC who are newly treated or relapsed

DEVICE

use the vein pump to pump drugs

During the first 14 days of the first cycle, the experimental drug was pumped daily with an intravenous pump. During cycles 2-4, subjects in group A were pumped with experimental drugs for 3 days and subjects in group B were pumped with experimental drugs for 7 days.

COMBINATION_PRODUCT

combination therapy

Combination therapy with chemotherapy drugs was used

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • xiaojian zhang · the director of the IRB

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2021-12-25
Completion
2022-10-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04942301 on ClinicalTrials.gov