Clinical Study of YQ1 Plus Cisplatin-based Chemotherapy in Advanced NSCLC EGFR Wild Type

NCT ID: NCT02967497

Last Updated: 2017-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Blank

No intervention, just observation.

Group Type NO_INTERVENTION

No interventions assigned to this group

YQ1 group

Cisplatin-based chemotherapy + YQ1

Group Type EXPERIMENTAL

YQ1

Intervention Type DRUG

Oral administered powder

Interventions

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YQ1

Oral administered powder

Intervention Type DRUG

Other Intervention Names

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a herbal medicine

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2016-02-003C

Identifier Type: -

Identifier Source: org_study_id

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