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Clinical Trial Summary

To observe the efficacy and safety of conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment of advanced squamous non-small cell lung cancer.


Clinical Trial Description

At present, Cindilimab combined with Gemcitabine and platinum chemotherapy has obtained the indication of first-line treatment for patients with advanced squamous non-small cell lung cancer, and has become one of the standard first-line treatment schemes for patients with advanced squamous non-small cell lung cancer. However, in DRIENT12 study, although it was confirmed that Cindilimab combined with Gemcitabine and platinum chemotherapy regimen can further delay or prevent the growth of cancer cells compared with placebo combined with Gemcitabine and platinum, in the process of treatment, due to serious adverse drug reactions, a considerable number of patients need to reduce the therapeutic dose of therapeutic drugs, and the body function of patients is damaged in this process, It will inevitably affect the treatment cycle, and even some patients stop treatment due to serious adverse drug reactions, and the serious adverse reactions of chemotherapy drugs will destroy the immune microenvironment, which will eventually affect the efficacy of the anti-cancer treatment. In addition, the mechanism of action of Cindilidone is different from that of chemotherapeutic drugs. It can kill tumor cells and inhibit tumor growth by activating human immune function. Therefore, in the combined scheme, reducing the dose of chemotherapy drugs to avoid too strong side effects damaging human immune function, destroying tumor cells to release antigens after the use of chemotherapy drugs, and continuing PD-1 monoclonal antibody to enhance human anti-tumor immunity may achieve the equivalent or better anti-tumor efficacy obtained in ORIENT12 research, and reduce treatment-related adverse reactions at the same time. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05312840
Study type Interventional
Source People's Hospital of Quzhou
Contact Xuru Jin
Phone 13857782369
Email hjh2018hjh@163.com
Status Recruiting
Phase Phase 4
Start date January 1, 2022
Completion date December 31, 2024

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