An interventional study of chemotherapy plus TCM 1&ICIs plusTCM2 and chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo in Lung Cancer, sponsored by Shanghai University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Shanghai University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
With the discovery of lung cancer driver genes, postoperative adjuvant therapy for lung cancers has been revolutionized. ADJUVANT, EVAN, EVIDNECE and IMPACT, have successively conducted efficacy and safety studies in the field of postoperative adjuvant therapy after generation EGFR-TKI. Adjuvant targeted therapy is also recommended by guidelines based on the significant improvement of DFS in mutation-positive patients. Unfortunately, 55% of NSCLC patients are driver gene-negative. Research in postoperative mutation-negative patients is relatively lagging behind. Chemotherapy remains the treatment of choice at this time. How to delay recurrence of metastasis in this population needs further study. Studies have shown that 1 year of adjuvant atezolizumab after chemotherapy in postoperative driver gene-negative patients significantly prolongs median DFS. For any PD-L1-expressing stage II-IIIa patients, adjuvant atezolizumab therapy has a median DFS of 42.3 months. Atezolizumab is recommended in the NCCN 2021 edition of clinical guidelines for patients with stage IIb-IIIa TPS ≥ 1%. In recent years, there has been great progress in the study of combined adjuvant therapy of Chinese medicine after lung cancer surgery. At present, research on TCM in the field of postoperative lung cancer is mainly focused on combined chemotherapy, which can reduce the occurrence of adverse events, improve quality of life, prevent recurrence and metastasis, and increase survival rate. More and higher-grade clinical evidence is needed to explore and validate the combination of TCM with immunotherapy.
Using a multicenter, randomized, double-blind, controlled prospective study, 367 patients with stage Ib-IIIb driver gene-negative NSCLC after undergoing radical surgery will be randomly divided into experimental and control groups, and postoperative adjuvant therapy will be administered in two phases: (i) chemotherapy phase: observation group (chemotherapy + TCM 1), control group (chemotherapy + TCM 1 placebo); (ii) immunization phase: observation group (ICIs + TCM2), control group (ICIs + TCM2 placebo). Treatment cycles will be 4 cycles of chemotherapy and 12 cycles of immunotherapy, and the indication for discontinuation will be the end of treatment or the patient's intolerance of treatment. Patients will be followed up regularly thereafter. The primary efficacy assessments are: disease-free survival (DFS); secondary efficacy assessments are: (1) quality of life: EORTC QLQ-LC43(V 4.0) scale; (2) changes in clinical signs of TCM; (3) biological indicators: ctDNA-MRD, peripheral blood immune factor series, plasma exosomal PD-L1; (4) overall survival (OS). An assessment of the toxic side effects and safety of the treatment regimen is also made by using CTC AE (V5.0). This regimen is expected to prolong disease-free survival and reduce toxic side effects. The study will provide evidence to optimize and promote the protocol of postoperative TCM combined with immunotherapy for lung cancer.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 367 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 102 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: chemotherapy plus TCM 1&ICIs plusTCM2
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.
Drug: chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo
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.
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.
This study also gives Pembrolizumab, Nivolumab, Durvalumab, Atezolizumab. No intervention listed here names it: that was found by reading the record.
Disease-free Survival(DFS)
Time from patient enrollment to date of objective tumour recurrence from any cause.
Time frame: 5 years
Overall Survival(OS)
The time from patient enrollment to date of any documented death from any cause.
Time frame: 5 years
Quality of Life Measurement Scale (EORTC QLQ-C30)
EORTC QLQ-C30 is assessed using and developed by the European Organzation for Research and Treatment of Cancer（EORTC）.QOL is evaluated by comparing changes in the quality of life scales before enrollment and every 1 month after treatment.The maximum score of QLQ-C30 scale is 100 and the minimum score is 0.Higher scores in functional areas and overall health represent better quality of life.Higher scores in the symptom area mean poorer quality of life.
Time frame: 5 years
Quality of Life Measurement Specific Module Scale for Patients with Lung Cancer (EORTC QLQ-LC13)
QOL is evaluated by comparing changes in the quality of life scales before enrollment and every 1 month after treatment.The maximum score of QLQ-LC13 scale is 100 and the minimum score is 0.Higher scores mean poorer quality of life.
Time frame: 5 years
TCM Symptoms Changes
TCM symptoms changes are according to the lung cancer symptom classification quantization table in "Guiding Principles for Clinical Research of Traditional Chinese Medicine in the Treatment of Lung Cancer (2002 Edition)". 1. Significant improvement: clinical syndrome scores decreased by≥ 70%. 2. Partial improvement: clinical syndrome scores decreased b≥30%; 3. No improvement: clinical syndrome scores no change, or change\<30%; 4. Exacerbation: clinical syndrome scores increases by≥30%.
Time frame: 5 years
Laboratory Indicator Evaluation Criteria
Refer to the "Guidelines for Clinical Research of New Drugs in Traditional Chinese Medicine (Trial)" (China Medical Science and Technology Press, 2002) to develop evaluation criteria: Improve: Any increase after treatment is ≥10% before treatment, or from abnormal to normal; Decrease: Anyone who falls ≥10% after treatment or changes from normal to abnormal after treatment; Stable: Anyone who rises or falls less than 10% after treatment compared with before treatment.
Time frame: 5 years
Circulating Exosome PD-L1
The circulating exosome PD-L1 evaluation will be measured before treatment, during chemotherapy, before immunotherapy, during immunotherapy, after treatment, and every 6 months during the follow-up period.
Time frame: 5 years
Molecular Residual Disease Circulating Tumor DNA(ctDNA-MRD)
The ctDNA-MRD evaluation will be measured before treatment, during chemotherapy, before immunotherapy, during immunotherapy, after treatment, and every 6 months during the follow-up period.
Time frame: 5 years
Safety Assessment Evaluated According to Common Toxicity Criteria
Percentage of Participants with Adverse Events. Safety assessment is evaluated according to common terminology criteria for adverse events(CTCAE) 5.0.
Time frame: 5 years
Started May 2023 (actual). Primary completion is estimated for Jun 2027, 49 months after the start.
Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 49 months is above that.
Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
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