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

Study Overview
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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.

Official Title
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An Open Label Study of UanQiHuoLi Tang Plus Cisplatin-based Chemotherapy in Advanced Epidermal Growth Factor Receptor Wild Type Non-small Cell Lung Cancer

Conditions
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Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: YQ1


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Blank<br>No intervention, just observation. | |
| Experimental: YQ1 group<br>Cisplatin-based chemotherapy + YQ1 | Drug: YQ1<br>* Oral administered powder<br>* Other names: a herbal medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Herbal medicine, Lung cancer