drugset / Trial / NCT03407300

A Safety and Efficacy Trial of Docetaxel With or Without XH1 in Non-small Cell Lung Cancer (NSCLC) Patients

NCT03407300 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, randomized, multicenter clinical study designed to evaluate its safety and efficacy by using Docetaxel with or without Traditional Chinese Medicine XH1 in patients with Stage ⅢB-Ⅳ Non-small Cell Lung Cancer (NSCLC) who failed with first-line Chemotherapy. The primary outcome measure includes progression-free survival (PFS) after treatment. Secondary outcome measures include collecting biomarkers before and during treatment, overall survival (OS), objective response rate (ORR), disease control rate (DCR), and patient's quality of life.

Timeline

Start
2018-02-01
Primary completion
2019-02-01
Completion
2019-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator XH1 Traditional medicine (herbal / TCM) — —
Comparator Docetaxel Small molecule — —