Trial intelligence / Profile preview

Docetaxel with or without TCM XH1 in Advanced NSCLC

NCT03407300Phase 2

Key facts

Status: Unknown
Start: Feb 2018
Primary completion: Feb 2019
Countries: 1
Sponsor: Haining Health-coming Biotech
Modality: TCM (Traditional Chinese Medicine)

Drugs: XH1
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, randomised trial of XH1 in non-small cell lung cancer (NSCLC) (2 arms), sponsored by Haining Health-coming Biotech. Primary endpoint: Progression-free survival at 12 months. Status: unknown.

Design

2 arms

Study design: Randomized

Docetaxel
Docetaxel monotherapy
Docetaxel + XH1
Docetaxel combined with Traditional Chinese Medicine XH1

Who it enrols

Patients with Stage IIIB or IV NSCLC who are EGFR negative and have failed first-line chemotherapy.

Endpoints

Primary

Progression-free survival12 months

Secondary

Overall survival12 months
Objective response rate12 months
Disease control rate12 months
Incidence of Treatment-Emergent Adverse Events12 months

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