MedTrace Logo

Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study

NCT04401059 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 744

Last updated 2023-12-27

No results posted yet for this study

Summary

This is a nationwide, multicenter and prospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.

Conditions

  • Carcinoma
  • Non-Small-Cell Lung Cancer
  • Adenocarcinoma

Interventions

DRUG

Elemene plus first or third generation EGFR-TKIs

Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day, continuous intravenous drip for 5 days. Continue to use Elemene Oral Emulsion. For specific usage, refer to the drug label. Elemene Oral Emulsion: 20ml: 176mg, 1 dose each time, 3 times a day. Use the Elemene Oral Emulsions until the disease progresses, the intolerable toxicity, the patient withdraws from the study, or dies for any reason. First or third generation EGFR-TKIs: refer to the drug label.

DRUG

First or third generation EGFR-TKIs

refer to the drug label.

Sponsors & Collaborators

  • LinkDoc Technology (Beijing) Co. Ltd.

    collaborator INDUSTRY

  • Tian Xie

    lead OTHER

Principal Investigators

  • Ziping Wang, PhD · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2025-09-30
Completion
2026-03-30

Countries

  • China

Study Locations

More Related Trials

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 NCT04401059 on ClinicalTrials.gov