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

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 2

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

Treatments: Drug: YQ1

Study type: Interventional

Funder types: Other

Identifiers

NCT02967497

2016-02-003C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Blank

No Intervention group

Description:

No intervention, just observation.

YQ1 group

Experimental group

Description:

Cisplatin-based chemotherapy + YQ1

Treatment:

Drug: YQ1