NCT02967497

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 2, 2017

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

November 16, 2016

Last Update Submit

December 30, 2016

Conditions

Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer

Keywords

ChemotherapyHerbal medicineLung cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    1 year

Study Arms (2)

Blank

NO INTERVENTION

No intervention, just observation.

YQ1 group

EXPERIMENTAL

Cisplatin-based chemotherapy + YQ1

Drug: YQ1

Interventions

YQ1DRUG

Oral administered powder

Also known as: a herbal medicine
YQ1 group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 18, 2016

Study Start

October 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

January 2, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share