Clinical trial · Interventional

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

NCT05834413CI-TRIAL-00111445recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
chemotherapy plus TCM 1&ICIs plusTCM2	Drug	—	UNRESOLVED
chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
chemotherapy plus TCM 1&ICIs plusTCM2
description
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.
interventionNames
1. Drug: chemotherapy plus TCM 1&ICIs plusTCM2
type
PLACEBO_COMPARATOR
label
chemotherapy plus TCM 1 placebo&ICIs plus TCM2 placebo
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 74 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: May 1, 2023
Primary completion: Jun 30, 2027
Completion: Jun 30, 2027
First posted: Apr 28, 2023
Last update posted: May 13, 2026
Enrollment: 367 (estimated)
Lead sponsor: Shanghai University of Traditional Chinese Medicine OTHER
Collaborators: Shanghai Pulmonary Hospital, Shanghai, China; Shanghai Chest Hospital; Fudan University; Shanghai Zhongshan Hospital; Ruijin Hospital
Keywords: non-small cell lung cancer, traditional Chinese medicine, postoperative adjuvant therapy, immune checkpoint inhibitors

Data updated 22 days agoSource updated May 13, 2026source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
China	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.