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

Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02967497
• Other study ID #: 2016-02-003C
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: November 16, 2016
• Last updated: December 30, 2016
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: July 2016
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 56
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• YQ1
Oral administered powder

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Yang Ming University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		1 year	No