Clinical Study on the Prevention of Driver Gene Negative II-IIIa Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Fudan University; Ruijin Hospital; Shanghai Chest Hospital; Shanghai Pulmonary Hospital, Shanghai, China; Shanghai Zhongshan Hospital

Criteria

Inclusion Criteria:

1. Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage II to IIIa non-small cell lung cancer.

2. Patients whose tissue or blood specimens tested negative for driver genes.

3. Patients who received their first chemotherapy within 8 weeks postoperatively.

4. Age ≥ 18 years ≤ 74 years, regardless of gender.

5. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 points.

6. absolute neutrophil value >1.5×109 /L, platelet count >80×109 /L, hemoglobin >90mg/dL; no abnormal liver and kidney function test results.

7. Understand and agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. 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.

2. Any medical condition with a life expectancy of less than 5 years, except for risk of recurrent lung cancer.

3. 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.

4. With a history of psychiatric disorders that are not easily controlled.

5. Patients who are pregnant or lactating.

6. Patients who are allergic to therapeutic drugs.