About this trial
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Obtain written informed consent before implementing any trial-related procedures;
Aged >= 18 years old;
Patients with locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not candidates for surgical treatment and cannot undergo curative radiotherapy or chemotherapy according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
Absence of the following gene mutations: EGFR gene, ALK fusion oncogene, ROS1, etc. For other types of gene mutations, patients without approved targeted therapies are allowed to be included;
Disqualifiers
Prior use of CCR8 drugs or other unapproved investigational drugs or treatments;
Known history of intolerance to PD-1 inhibitor therapy;
Receipt of any approved systemic anti-cancer therapy or systemic immunostimulant treatment within 28 days prior to the start of the study treatment;
Use of traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within the first 2 weeks prior to first dosing;
Trial design
Parallel
Treatments tested in this trial
LM-108 antibody and sintilimab
DrugCohort 1 receive LM-108 monoclonal antibody combined with sintilimab
LM-108 antibody and sintilimab and chemotherapy
DrugCohort 2 receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate
Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.
Secondary outcomes
Progression-free Survival
Progression-free survival measures the length of time during and after treatment that a patient lives with the disease without it progressing.
Duration of response
Duration of response refers to the length of time during which a patient's tumor remains in remission or shows a positive response to treatment.
Overall Survival
Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives.
Sponsors and contacts
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