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Low-dose Gemcitabine Combined With Nivolumab for Second-line and Above Line Treatment of NSCLC

NCT04331626 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-04-02

No results posted yet for this study

Summary

In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors, and some patients can achieve long-term survival. However, despite the encouraging clinical data, only a small number of people have benefited. Therefore, how to further improve the efficacy of immunotherapy and expand the benefit population has become the focus of this field.

The applicant was previously published in Oncoimmunology (2017; E1331807) pointed out in the above article: MDSC is a group of immunosuppressive cells, the number of this group of cells in the body of cancer patients is more than normal, its presence affects the proliferation, activation and function of T cells, is one of the important factors affecting the efficacy of immunocheckpoint inhibitors. Therefore, ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions: first, they can kill or inactivate tumor cells to release tumor-specific or associated antigens; Second, MDSC and other immunosuppressive cells can be eliminated. Third, the number and function of T cells were not affected.

Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer. Myelosuppression is the dose - limiting toxicity of gemcitabine, which includes lymphocytopenia. Therefore, if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody, the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine. Therefore, we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene, and the adverse reactions were relatively mild.

This study is a phase IV, open, non-randomized, single-arm, single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes. Fifty subjects will be enrolled in this study. The primary endpoint of the study was ORR, while secondary endpoints included DCR, PFS, and OS.

Conditions

  • Non-small Cell Lung Cancer Metastatic

Interventions

DRUG

Gemcitabine Injectable Product

Low dose chemotherapy drug combined with pd-1 antibody, Gemcitabine should be administered at 50% of the recommended dose, i.e. 500mg/m2, for 30 minutes by intravenous drip. Day 1 and day 8 administration.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Zibing Wang, Doctor · Henan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2022-12-31
Completion
2023-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331626 on ClinicalTrials.gov