Lung CancerNCT05834413
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
A study testing chemotherapy plus TCM 1&ICIs plusTCM2 in people with Lung Cancer, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- chemotherapy plus TCM 1&ICIs plusTCM2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
Yin, 86+021-65161782-6160, yyyyllwyh@163.com
About this study
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- chemotherapy plus TCM 1&ICIs plusTCM2, chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo
- Keywords
- non-small cell lung cancer, traditional Chinese medicine, postoperative adjuvant therapy, immune checkpoint inhibitors
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy plus TCM 1&ICIs plusTCM2Drug
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 plus TCM 1placebo &ICIs plus TCM2 placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy plus TCM 1&ICIs plusTCM2 | Experimental | 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. Receives: Drug: chemotherapy plus TCM 1&ICIs plusTCM2 |
| chemotherapy plus TCM 1 placebo&ICIs plus TCM2 placebo | Placebo comparator | 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. Receives: Drug: chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival(DFS)
Time from patient enrollment to date of objective tumour recurrence from any cause.
Measured: 5 years
Secondary outcomes (8)
Overall Survival(OS)
The time from patient enrollment to date of any documented death from any cause.
Measured: 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.
Measured: 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.
Measured: 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)".
- Significant improvement: clinical syndrome scores decreased by≥ 70%.
- Partial improvement: clinical syndrome scores decreased b≥30%;
- No improvement: clinical syndrome scores no change, or change<30%;
- Exacerbation: clinical syndrome scores increases by≥30%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 367 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital, Fudan University, Shanghai Zhongshan Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Ling Xu, Shanghai University of Traditional Chinese Medicine
- Investigators
- Ling Ling, MD & PhD, Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834413
- Sponsor's protocol ID
- 22Y31920400
- Status last verified
- Nov 2025
- First submitted
- 23 Mar 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05834413
- Acronym / sponsor ID
- 22Y31920400
- Conditions
- Lung Cancer
- Keywords
- non-small cell lung cancer, traditional Chinese medicine, postoperative adjuvant therapy, immune checkpoint inhibitors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 367 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital, Fudan University, Shanghai Zhongshan Hospital, Ruijin Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy plus TCM 1&ICIs plusTCM2 | Experimental | Drug: chemotherapy plus TCM 1&ICIs plusTCM2Phase1： 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 comparator | Drug: chemotherapy plus TCM 1placebo &ICIs plus TCM2 placeboPhase1： 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy plus TCM 1&ICIs plusTCM2In 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. | Drug | chemotherapy plus TCM 1&ICIs plusTCM2 |
| chemotherapy plus TCM 1placebo &ICIs plus TCM2 placeboChemotherapy：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. | Drug | chemotherapy plus TCM 1 placebo&ICIs plus TCM2 placebo |
Primary outcome
Disease-free Survival(DFS)
Time frame: 5 years
Time from patient enrollment to date of objective tumour recurrence from any cause.
8 secondary outcomes
Overall Survival(OS)
Time frame: 5 years
Quality of Life Measurement Scale (EORTC QLQ-C30)
Time frame: 5 years
Quality of Life Measurement Specific Module Scale for Patients with Lung Cancer (EORTC QLQ-LC13)
Time frame: 5 years
TCM Symptoms Changes
Time frame: 5 years
Laboratory Indicator Evaluation Criteria
Time frame: 5 years
Circulating Exosome PD-L1
Time frame: 5 years
Molecular Residual Disease Circulating Tumor DNA(ctDNA-MRD)
Time frame: 5 years
Safety Assessment Evaluated According to Common Toxicity Criteria
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ling Ling, MD & PhD principal investigator
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chemotherapy plus TCM 1&ICIs plusTCM2 in people with Lung Cancer, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Xu, MD & PhD (86+021-65161782-1662, xulq67@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival(DFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.