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

NCT03407300 | Unknown Phase 2

• 1 other identifier: Alphacait-XH1-201711
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Non-small Cell Lung Cancer (NSCLC), XH1

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Time from randomization until disease progression or death

  12 month

Secondary Outcomes (4)

• Overall survival (OS)

  12month

• Objective response rate (ORR)

  12 month

• Disease control rate (DCR)

  12 month

• Incidence of Treatment-Emergent Adverse Events

  12 month

Other Outcomes (1)

• Biomarkers

  12 months

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

Stage III-IV NSCLC patients who failed first-line chemotherapy will be treated with Docetaxel alone.

Drug: Docetaxel

Docetaxel plus XH1

ACTIVE COMPARATOR

Stage III-IV NSCLC patients who failed first-line chemotherapy will be treated with Docetaxel plus Chinese traditional medicine XH1.

Drug: Docetaxel; Drug: Chinese traditional medicine XH1

Interventions

Docetaxel DRUG

To evaluate the safety and efficacy of Docetaxel alone in stage III-IV NSCLC patients

Docetaxel; Docetaxel plus XH1

Chinese traditional medicine XH1 DRUG

To evaluate the safety and efficacy of Docetaxel combined with Chinese tradition medicine XH1 in stage III-IV NSCLC patients

Docetaxel plus XH1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically diagnosed IIIB or IV non-small cell lung cancer and EGFR negative
• Previously accepted first-line standard treatment failure or recurrence
• At least one measurable lesion
• From the last radiotherapy interval of at least 4 weeks, recovery from acute toxicity of radiation, prophylactic brain radiotherapy or palliative bone metastases lesions except radiotherapy
• Any gender, age ≥18 years
• ECOG PS : 0-2 points
• Expected survival ≥ March
• The level of organ function meets the following criteria (1) subject to the standard blood test: ANC ≥ 1.5 × 10 9 / L, PLT ≥ 8 0 × 10 9 / L, Hb ≥ 100 g / L (2) biochemical tests must meet the following criteria: TBIL \<1.5 × U LN, ALT, AST \<2 .5 × ULN ( if liver ALT, AST can be \<5 × U LN), BUN, and Cr ≤ 1 × ULN)
• Patients must be willing to eight weeks after the use of appropriate methods of contraception and the last administration of the test drug during the test, or surgically sterile
• Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up

You may not qualify if:

• Symptomatic brain metastasis (could still enroll into the study if treatment finished 21 days prior to the enrollment and the patient is stable, but brain MRI, CT or angiogram is needed to rule out no intracranial hemorrhage)
• Following cardiac disease: second-degree or above cardiac ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval male\>450 ms, female\>470ms), according to NYHA criteria, III to IV cardiac insufficiency, or echocardiogram reveals left ventricular ejection fraction (LVEF) \<50%
• History of pulmonary interstitial lung disease or active interstitial lung disease;
• Coagulation dysfunction (INR \>1.5 or PT\>ULN+ 4sec, or PTT\>1.5 ULN), with bleeding tendency or currently receiving thrombolysis therapy or anticoagulation treatment;
• Major surgery, severe traumata, fracture or ulcers within past 4 weeks.
• Active infections requiring antimicrobial therapy (e.g., requires the use of antimicrobial drugs, antiviral, antifungal therapy)
• Participation of other cancer chemotherapy clinical study within past 4 weeks;
• History of uncured coexisting cancer, not including cured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer
• Pregnant or breast feeding women; fertile patients not willing or able to take effective contraceptive measures
• Any circumstances that might affect the proceeding of the clinical trial and/or research result analysis, as determined by the clinical investigator(s)

Sponsors & Collaborators

• Haining Health-Coming Biotech Co., Ltd.: lead
• Alphacait, LLC: collaborator

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Enguo Chen, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Haizhou Lou, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Li, MD

CONTACT

86-137-50766911; libinmadison@yahoo.com

Haizhou Lou, MD

CONTACT

86-571-86006926; louhz09@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: June, 2019

Locations

CN (1)