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

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haining Health-Coming Biotech Co., Ltd.
• Collaborator: Alphacait, LLC
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

1. Pathologically diagnosed IIIB or IV non-small cell lung cancer and EGFR negative

2. Previously accepted first-line standard treatment failure or recurrence

3. At least one measurable lesion

4. 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

5. Any gender, age ≥18 years

6. ECOG PS : 0-2 points

7. Expected survival ≥ March

8. 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)

9. 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

10. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up

Exclusion Criteria:

1. 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)

2. 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%

3. History of pulmonary interstitial lung disease or active interstitial lung disease;

4. 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;

5. Major surgery, severe traumata, fracture or ulcers within past 4 weeks.

6. Active infections requiring antimicrobial therapy (e.g., requires the use of antimicrobial drugs, antiviral, antifungal therapy)

7. Participation of other cancer chemotherapy clinical study within past 4 weeks;

8. History of uncured coexisting cancer, not including cured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer

9. Pregnant or breast feeding women; fertile patients not willing or able to take effective contraceptive measures

10. Any circumstances that might affect the proceeding of the clinical trial and/or research result analysis, as determined by the clinical investigator(s)