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

Phase 2

• Conditions: Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer
• Interventions: Drug: YQ1

• Registration Number: NCT02967497
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-10
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-01-02
• Primary Completion: 2017-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YQ1 group	YQ1	Cisplatin-based chemotherapy + YQ1

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	1 year