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Efficacy and safety of Serplulimab combined with platinum-based chemotherapy and H1 receptor antagonist (desloratadine) in the First-line Treatment for locally advanced or metastatic non-small cell lung cancer:a prospective randomized controlled study

Efficacy and safety of Serplulimab combined with platinum-based chemotherapy and H1 receptor antagonist (desloratadine) in the First-line Treatment for locally advanced or metastatic non-small cell lung cancer:a prospective randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125150
Enrollment
Unknown
Registered
2026-05-21
Start date
2025-12-03
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Experimental group:Desloratadine
Control group:None

Sponsors

Ningbo Medical Centre Lihuili Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old and = 3 months; 5.ECOG score 0 or 1; 6.No severe dysfunction of important organs such as the heart, liver, or kidneys; 7.There was at least one radiographically measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST version 1.1); 8.The lesions to be collected within one week prior to the sample collection were not subjected to radiotherapy. 9.Sign a written informed consent before implementing any procedures related to the tria;

Exclusion criteria

Exclusion criteria: 1.Expected survival time <3 months; 2.With known driver gene mutations such as EGFR/ALK/ROS1; 3.Patients with lung metastasis of other primary malignant tumors; 4.With brain metastasis and symptoms present but not receiving effective treatment; 5.Within a week, the affected areas that needed sample collection underwent radiotherapy; 6.Having previously received immunotherapy or any treatment related to the drug under study; 7.Allergic to sorlumab or platinum-based chemotherapy drugs, etc. 8.Companied by severe active infections, diseases of the heart, liver, kidneys and immune and hematopoietic systems; 9.Patients with rare genetic galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; 10.There was no radiographically measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST version 1.1); 11.Pregnant women or women who are breastfeeding; 12.Subjects with mental disorders who are unable to cooperate with treatment;

Design outcomes

Primary

MeasureTime frame
Progression free survival;Overall survival;Objective remission rate;Adverse event;Duration of Response (DoR);

Secondary

MeasureTime frame
Histamine level;

Countries

China

Contacts

Public Contactxushuguang

Ningbo Medical Centre Lihuili Hospital

xushuguang2008@126.com+86 574 5583 6245

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026