Non-Small Cell Lung Cancer
Conditions
Interventions
A:WSD0922-FU 120mg
B:WSD0922-FU 160mg
C:WSD0922-FU 200mg
D:WSD0922-FU 240mg
A-B-C-D:Osimertinib 80mg
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Provide a signed and dated written informed consent form prior to any study-specific procedures, sampling, and analysis. 2.Male or female subjects aged >= 18 years. 3.Histologically or cytologically confirmed diagnosis of non-small cell lung adenocarcinoma. 4.Performance status: Subjects with Eastern Cooperative Oncology Group (ECOG) PS 0-1. 5.At least one measurable target lesion that has not received prior radiotherapy and is not selected for biopsy during the study. 6.Radiographic disease progression during continuous treatment with a prior third-generation EGFR TKI. 7.Detection of EGFR mutations known to be associated with EGFR TKI sensitivity. Subjects must use highly effective contraceptive measures. 8.Subjects are allowed to take a stable daily dose of dexamethasone not exceeding 2 mg.
Exclusion criteria
Exclusion criteria: 1.Have received more than 2 lines of prior systemic drug therapy for advanced non-small cell lung cancer (NSCLC). 2.Subjects currently receiving (or unable to discontinue use before the first dose of study drug) medications or herbal supplements known to be strong CYP3A4 inducers (at least 3 weeks prior). 3.At the start of study treatment, adverse reactions caused by prior treatment are greater than Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia and Grade 2 peripheral neuropathy related to prior platinum-based therapy. 4.Symptomatic cerebral complications requiring urgent neurosurgical intervention or medical treatment (e.g., mannitol). 5.Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension. 6.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the prepared product, or a history of prior intestinal resection that would impair the adequate absorption of WSD0922-FU and osimertinib. 7.Any standard cardiac disease: mean resting corrected QT interval (QTcF) > 470 milliseconds. 8.A history of prior interstitial lung disease (ILD), radiation pneumonitis requiring steroid treatment, or evidence of any clinically active interstitial lung disease. 9.Any laboratory values indicating insufficient bone marrow reserve or organ function. 10.A history of any allergic reactions. 11.Men and women of reproductive potential who do not use effective contraceptive methods. 12.Subjects deemed unsuitable for study participation by the investigator if they cannot comply with any study procedures, restrictions, and requirements. 13.Subjects with known or confirmed gene mutations such as EGFR T790M, MET gene abnormalities, or EGFR exon 20 insertion mutations for which there are existing clinical treatment regimens or who are not suitable for receiving the study drugs. 14.Known intracranial hemorrhage unrelated to the tumor. 15.Subjects must not have received enzyme-inducing antiepileptic drugs for treatment within at least 2 weeks before the first dose of study drug. 16.Prior allogeneic bone marrow transplantation. 17.Infusion of non-leukocyte-depleted whole blood within 120 days from the date of genetic sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD/RP2DDLT;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR,DoR,PFS;OS;ORR;Safety(AE Incidence, Severity, and Causality with Study Drugs); | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai East Hospital
Outcome results
None listed