RecruitingNot ApplicableNCT05834413

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

Sponsor

Shanghai University of Traditional Chinese Medicine

Enrollment

367 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 74 Years

Inclusion Criteria7

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.

Exclusion Criteria6

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.

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Interventions

DRUGchemotherapy plus TCM 1&ICIs plusTCM2

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.

DRUGchemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo

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.