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
1 other identifier
interventional
367
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started May 2023
Typical duration for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 13, 2026
November 1, 2025
4.2 years
March 23, 2023
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival(DFS)
Time from patient enrollment to date of objective tumour recurrence from any cause.
5 years
Secondary Outcomes (8)
Overall Survival(OS)
5 years
Quality of Life Measurement Scale (EORTC QLQ-C30)
5 years
Quality of Life Measurement Specific Module Scale for Patients with Lung Cancer (EORTC QLQ-LC13)
5 years
TCM Symptoms Changes
5 years
Laboratory Indicator Evaluation Criteria
5 years
- +3 more secondary outcomes
Study Arms (2)
chemotherapy plus TCM 1&ICIs plusTCM2
EXPERIMENTALPhase1： 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 placebo
PLACEBO COMPARATORPhase1： 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.
Interventions
Chemotherapy：Vincristine/paclitaxel/docetaxel/pemetrexed/gemcitabine plus cisplatin/carboplatin：administrated for patients with NSCLC requiring post-operative adjuvant therapy. ICIs：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab：administrated for patients with NSCLC requiring post-operative adjuvant therapy.
In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang and Xu Ling. Package of granules is made into two types with functions such as tonifying the stomach and nourishing the blood recipe, benefiting Qi Yin and detoxification and resolving masses recipe. The herbal treatment is adapted to the syndromes. Chemotherapy：Vincristine/paclitaxel/docetaxel/pemetrexed/gemcitabine plus cisplatin/carboplatin：administrated for patients with NSCLC requiring post-operative adjuvant therapy. ICIs：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab：administrated for patients with NSCLC requiring post-operative adjuvant therapy.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai University of Traditional Chinese Medicinelead
- Shanghai Pulmonary Hospital, Shanghai, Chinacollaborator
- Shanghai Chest Hospitalcollaborator
- Fudan Universitycollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Ruijin Hospitalcollaborator
Study Sites (1)
YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ling Ling, MD & PhD
Shanghai University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 28, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 13, 2026
Record last verified: 2025-11