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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT05834413

Run by

Shanghai University of Traditional Chinese Medicine

People needed

367

Starts

2023-05-01

Expected to finish

2027-06-30

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 pregnant or lactating.
• Patients who are allergic to therapeutic drugs.

Where it is running

• YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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