NCT05834413Recruiting
Clinical Study on the Prevention of Driver Gene Negative Ib-IIIb Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
This project adopts a prospective, multicenter, randomized controlled clinical study to investigate the treatment of TCM in postoperative patients with driver gene negative lung cancer, according to two phases of postoperative adjuvant therapy: (i) chemotherapy phase immunotherapy phase. In this study, 367 patients (183 in the control group and 184 in the trial group) will be observed over 4 years, and the quality of life, toxic effects and safety of this therapy will be investigated. This study will provide evidence-based evidence for the establishment and optimization of a new model of postoperative staged TCM with adjuvant chemo-immunotherapy for lung cancer.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 367 (estimated)
- First submitted
- 23 Mar 2023
- Start date
- 1 May 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Diseases
- Lung cancer
- NCT number
- NCT05834413
What you commit to
- Study type: Interventional
- Planned participants: 367
- From 1 May 2023 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having unresectable or metastatic disease, pathology reports without a clear pathological diagnosis, showing the presence of residual lesions at the microscopic surgical margins, and surgical residual lesions.
- Any medical condition with a life expectancy of less than 5 years, except for risk of recurrent lung cancer.
- Current malignant disease or history of malignant disease (except resected NSCLC), combined with serious diseases of the heart, liver, kidney and hematopoietic system, diagnosed and/or requiring treatment within the past three years.
- With a history of psychiatric disorders that are not easily controlled.
- Patients who are allergic to therapeutic drugs.
Other
- Patients who are pregnant or lactating.
Who the study is looking for
- Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage Ib to IIIb non-small cell lung cancer.
- Patients whose tissue or blood specimens tested negative for driver genes.
- Patients who received their first chemotherapy within 8 weeks postoperatively.
- Age ≥ 18 years ≤ 74 years, regardless of gender.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 points.
- absolute neutrophil value \>1.5×109 /L, platelet count \>80×109 /L, hemoglobin \>90mg/dL; no abnormal liver and kidney function test results.
- Understand and agree to participate in this study and sign the informed consent form.
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.