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A randomized controlled study of Yiqi Chutan Fa (Yifei Sanjie Wan) combined with platinum doublets for the treatment of mid and advanced Non-small Cell Lung Cancer in newly patients with driver gene-negative

A randomized controlled study of Yiqi Chutan Fa(Yifei Sanjie Wan) combined with platinum doublets for the treatment of mid and advanced Non-small Cell Lung Cancer in newly patients with driver gene-negative

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004439
Enrollment
Unknown
Registered
2020-11-06
Start date
2020-12-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Interventions

Sponsors

The First Affiliated Hospital of Guangzhou University of Traditonal Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are new confirmed as Non-small Cell Lung Cancer by histopathology and/or cytopathology can use chemotherapy as primary treatment. 2. Men and women range in age from 18-75 years. 3. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-2. 4. Lifetime is expected to be 3 months or more. 5. Patients at least have one measurable target lesion examined by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 6. Informed consent form is signed willingly by all study participants.

Exclusion criteria

Exclusion criteria: 1. The result of genetic testing is positive for one of the three biomarkers (Epidermal growth factor receptor [EGFR], Anaplastic lymphoma kinase [ALK] and c-ros oncogene receptor kinase [ROS]). 2. They are intended to immunotherapy. 3. They are intended to radiotherapy. 4. The status of brain metastasis (BM) is unstable. 5. Pregnant women or breast feeding women. 6. Mental illness or mental retardation. 7. Patients are intolerance or allergic to study drug.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
Overall Survival;Disease Control Rate;One-year survival rate;The duration of drug use;Quality of Life;Objective Response Rate;

Countries

China

Contacts

Public ContactLizhu Lin

The First Affiliated Hospital of Guangzhou University of Traditonal Chinese Medicine

lizhulin1278@163.com020-36596356

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026