Back to resultsClinical Study of YQ1 Plus Cisplatin-based Chemotherapy in Advanced NSCLC EGFR Wild Type
Primary Purpose
Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
YQ1
Sponsored by
About this trial
This is an interventional supportive care trial for Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer focused on measuring Chemotherapy, Herbal medicine, Lung cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is advanced/metastatic (stage IIIB/IV), EGFR/ALK wild type.
- Subjects who plan to receive cisplatin-based chemotherapy.
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Exclusion Criteria:
- ECOG performance status >= 3
- WBC =< 4,000 cells/μl, ANC =< 1,500/mcL, Platelets =< 100,000/mcL , Hemoglobin =< 9 g/dL,
- Total bilirubin >= 1.5 x upper limit of normal (ULN), AST >= 1.5x ULN, ALT >= 2.5 x ULN, Creatinine >= 1.5x ULN
- Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure.
- Chronic or current Inflammatory Bowel Disease, post-surgery of intestine, Lynch syndrome, FAP, Peutz-Jegher.
- History of allergic reactions cisplatin
- Pregnant women are excluded; breastfeeding should be discontinued prior to study entry.
- Received any other clinical trail at the same time.
- Current dementia or other cognitive disorders.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Blank
YQ1 group
Arm Description
No intervention, just observation.
Cisplatin-based chemotherapy + YQ1
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02967497
First Posted
November 16, 2016
Last Updated
December 30, 2016
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT02967497
Brief Title
Clinical Study of YQ1 Plus Cisplatin-based Chemotherapy in Advanced NSCLC EGFR Wild Type
Official Title
An Open Label Study of UanQiHuoLi Tang Plus Cisplatin-based Chemotherapy in Advanced Epidermal Growth Factor Receptor Wild Type Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK wild type non-small cell lung cancer, stage IIIB-IV.
Detailed Description
This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK wild type non-small cell lung cancer, stage IIIB-IV. Chinese herbal medicine was known to be beneficial adjuvant or alternative medicine for cancer treatment. However, the mechanism was unknown. This study wants to investigate the effect and mechanism of YQ1, which was proved to improve the antitumor immunity, to inhibit cancer progression, and to prolong overall survival of lung adenocarcinoma in a series of preclinical studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer
Keywords
Chemotherapy, Herbal medicine, Lung cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blank
Arm Type
No Intervention
Arm Description
No intervention, just observation.
Arm Title
YQ1 group
Arm Type
Experimental
Arm Description
Cisplatin-based chemotherapy + YQ1
Intervention Type
Drug
Intervention Name(s)
YQ1
Other Intervention Name(s)
a herbal medicine
Intervention Description
Oral administered powder
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is advanced/metastatic (stage IIIB/IV), EGFR/ALK wild type.
Subjects who plan to receive cisplatin-based chemotherapy.
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Exclusion Criteria:
ECOG performance status >= 3
WBC =< 4,000 cells/μl, ANC =< 1,500/mcL, Platelets =< 100,000/mcL , Hemoglobin =< 9 g/dL,
Total bilirubin >= 1.5 x upper limit of normal (ULN), AST >= 1.5x ULN, ALT >= 2.5 x ULN, Creatinine >= 1.5x ULN
Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure.
Chronic or current Inflammatory Bowel Disease, post-surgery of intestine, Lynch syndrome, FAP, Peutz-Jegher.
History of allergic reactions cisplatin
Pregnant women are excluded; breastfeeding should be discontinued prior to study entry.
Received any other clinical trail at the same time.
Current dementia or other cognitive disorders.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of YQ1 Plus Cisplatin-based Chemotherapy in Advanced NSCLC EGFR Wild Type
We'll reach out to this number within 24 hrs