Non-Small Cell Lung Cancer
Conditions
Interventions
Trial group:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years at the time of signing the informed consent form; 2. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC); 3. Confirmed EGFR-sensitive mutations in tumor tissue samples from patients diagnosed with NSCLC, including exon 19 deletions or exon 21 L858R substitution mutations, either alone or coexisting with other EGFR mutations; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, with no deterioration within the past 2 weeks, and a minimum expected survival of 12 weeks; 5. Patients must have at least one measurable tumor lesion at baseline, with the longest diameter >= 10 mm (or >= 15 mm in the short axis for lymph nodes). The selected measurement method must allow accurate and repeated measurements, such as computed tomography (CT) or magnetic resonance imaging (MRI). If only one measurable lesion exists, it may be used as the target lesion, and baseline tumor assessment should be performed at least 14 days after diagnostic biopsy; 6. Women of childbearing potential must use adequate contraception from screening until 3 months after discontinuation of study treatment, and must not breastfeed; 7. Male patients must use barrier contraceptive methods (i.e., condoms) until 3 months after discontinuation of study treatment.
Exclusion criteria
Exclusion criteria: 1.Subjects with concomitant diseases that, in the investigator’s judgment, would seriously compromise subject safety or affect the completion of the study, or subjects considered unsuitable for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Key PK parameters of Furmonertinib and its metabolites: Ctrip and steady-state drug concentration range; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactYan Liu
Shanghai General Hospital
Outcome results
None listed