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

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

This trial tests whether adding staged traditional Chinese herbal medicine to standard adjuvant chemotherapy followed by immune checkpoint inhibitors can reduce recurrence and improve quality of life for adults with driver-gene–negative stage Ib–IIIb non-small cell lung cancer after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 367 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Shanghai University of Traditional Chinese Medicine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, atezolizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05834413 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–74 years with complete (R0) resection of stage Ib–IIIb NSCLC, negative driver‑gene test results, ECOG performance status ≤2, adequate blood and organ function, and who begin first adjuvant chemotherapy within eight weeks after surgery.

Not a fit: Patients with unresectable or metastatic disease, positive driver‑gene mutations, a life expectancy under five years, or significant organ dysfunction are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding staged TCM to adjuvant chemotherapy and immune checkpoint inhibitors could lower recurrence risk, reduce side effects, and improve post‑surgical quality of life.

How similar studies have performed: Adjuvant atezolizumab has shown DFS benefit in some driver‑negative patients and prior studies of TCM plus chemotherapy report reduced toxicity and better quality of life, but the specific staged TCM approach combined sequentially with chemo and immunotherapy is relatively novel and not widely tested.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions Lung Cancer; non-small cell lung cancer; traditional Chinese medicine; postoperative adjuvant therapy; immune checkpoint inhibitors