advanced lung cancer trial subjects /patients
Conditions
Interventions
Safety indicators:None
QSP - Digital Twin Model Virtual Patient Group:None
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 70 years old; 2.Histologically or cytologically confirmed locally advanced unresectable or metastatic lung cancer; 3.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0–2. Patients with ECOG PS 3 caused by tumor burden and expected to improve after treatment may be enrolled upon investigator’s assessment; 4.The patient or their legal representative voluntarily signs the written informed consent form approved by the IRB/IEC.
Exclusion criteria
Exclusion criteria: 1.Known severe hypersensitivity to active ingredients or excipients of the study drug; 2.Persistent heart failure of NYHA Class III or higher; refractory arrhythmia; active autoimmune disease requiring immunosuppressants equivalent to >=10 mg prednisone per day; 3.Pulmonary infection complicated with severe hypoxemia (SpO2 < 88%) occurring within the last 4 weeks; 4.Requirement for urgent cranial radiotherapy or surgical decompression; 5.Symptomatic cerebral hemorrhage or uncontrolled seizure within the past 14 days; 6.Pregnant or breastfeeding women; 7.Any medical or social factors that may affect treatment compliance or increase patient risk may be considered as exclusion criteria, with full documentation and rationale provided.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prediction accuracy of the objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Median progression-free survival (mPFS);Overall Survival(OS);Disease control rate (DCR);Safety indicators; | — |
Countries
China
Contacts
Public ContactYang Hong
Sun Yat-sen University Cancer Center
Outcome results
None listed