Staged Chinese herbal therapy plus chemotherapy and immune checkpoint blockers to prevent recurrence in driver-gene–negative stage Ib–IIIb lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized controlled study enrolling 367 patients with completely resected, driver-gene–negative stage Ib–IIIb non-small cell lung cancer to compare staged traditional Chinese medicine (TCM) plus standard adjuvant chemotherapy followed by immune checkpoint inhibitors versus matched TCM placebos with the same systemic therapy. Patients are randomized roughly 1:1 to receive TCM formulas during the chemotherapy phase (TCM1) and during the immunotherapy phase (TCM2) or matched placebos, with treatment and four years of follow-up. Outcomes include recurrence and metastasis rates, quality of life measures, treatment toxicities, and safety. The trial is run at Shanghai University of Traditional Chinese Medicine and affiliated Shanghai hospitals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage Ib to IIIb 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.

Where it's running

• YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Ling Ling, MD & PhD — Shanghai University of Traditional Chinese Medicine
• Study coordinator: Ling Xu, MD & PhD
• Email: xulq67@aliyun.com
• Phone: 86+021-65161782-1662

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.