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Tests herbal medicine with chemotherapy and immunotherapy after lung cancer surgery

Tests staged Chinese herbal medicine with chemo and immunotherapy in lung cancer patients after surgery.

Key facts

Who runs it
Shanghai University of Traditional Chinese Medicine
Where
Shanghai, ChinaSee the site
Trial code
Registry title
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
Status
Recruiting
People taking part
367 people, planned
Started
1 May 2023
Expected to end
30 Jun 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • chemotherapy plus TCM 1&ICIs plusTCM2
  • chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo
Record updated
13 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 74 who had complete surgery for stage Ib to IIIb non-small cell lung cancer. Their tumor tests must be negative for driver genes.

Age
18 to 74 years
Sex
All sexes can join.
Disease stage
Non-small cell lung cancer, stage Ib to IIIb, fully removed by surgery (R0), confirmed by pathology after surgery.
Earlier treatment
Must have had complete surgery. Must have received the first chemotherapy within 8 weeks after surgery.
Biomarker or test result
Tissue or blood tests must be negative for driver genes.

Main reasons for not taking part

  • Disease that cannot be removed by surgery or has spread
  • Tumor cells left at the surgical margins or leftover lesions after surgery
  • Current or past other cancer (except the removed lung cancer), or serious heart, liver, kidney or blood disease
  • Hard-to-control psychiatric disorder
  • Pregnant or breastfeeding, or allergic to the study drugs

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Patients who are pregnant or lactating

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 74 years old?

Where in China

  • YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese MedicineShanghai, ChinaContact: YinTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • chemotherapy plus TCM 1&ICIs plusTCM2Treatment being tested

    Phase1： Chemotherapy：Proposed platinum-containing two-drug adjuvant chemotherapy, vincristine/paclitaxel/docetaxel/pemetrexed/gemcitabine plus cisplatin/carboplatin within 8 weeks after surgery, according to CSCO guidelines (2022). TCM1 granules：oral granules, "HeWeiYangXueFang" , twice a day, every 21 days for 4 cycles. Phase 2： One of the following agents may be selected after chemotherapy ：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab.A total of 12 cycles will be performed or the patient will discontinue the drug due to intolerable toxic side effects. TCM2 granules：oral granules, "FeiPingFang" , twice a day, every 21 days for 12 cycles.

  • chemotherapy plus TCM 1 placebo&ICIs plus TCM2 placeboPlacebo, for comparison

    Phase1： Chemotherapy：Proposed platinum-containing two-drug adjuvant chemotherapy, vincristine/paclitaxel/docetaxel/pemetrexed/gemcitabine plus cisplatin/carboplatin within 8 weeks after surgery, according to CSCO guidelines (2022). Placebo1 granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect , twice a day, every 21 days for 4 cycles. Phase 2：One of the following agents may be selected after chemotherapy：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab.A total of 12 cycles will be performed or the patient will discontinue the drug due to intolerable toxic side effects. Placebo2 granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, twice a day, every 21 days for 12 cycles.

    Treatment: chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests herbal medicine with chemotherapy and immunotherapy after lung cancer surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05834413, who can take part
Record updated
13 May 2026