Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer
Conditions
Keywords
Chemotherapy, Herbal medicine, Lung cancer
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.
Interventions
DRUGYQ1
Oral administered powder
Sponsors
National Yang Ming Chiao Tung University
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | 1 year |
Outcome results
None listed