A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Gā¦ (NCT06670196) | Clinical Trial Compass
RecruitingPhase 3
A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
China420 participantsStarted 2024-11-27
Plain-language summary
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Aged ā„18 years to ā¤75 years at the time of signing the informed consent form (ICF), regardless of gender.
ā. Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC not eligible to radical surgery and/or radical radiotherapy.
ā. No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
ā. Histologically or cytologically confirmed EGFR-sensitive mutations.
ā. Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible.
ā. At least one target lesion assessed by the investigator based on RECIST v1.1.
ā. ECOG performance status score of 0 or 1 within 7 days prior to randomization.
ā. Life expectancy ā„ 12 weeks.
Exclusion criteria
ā. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%.
ā. Subjects who have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
ā. Subjects who have received any of the following therapies (including the adjuvant/neoadjuvant therapy):
What they're measuring
1
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: Randomization up to approximately 36 months
ā. Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
ā. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or central nervous system (CNS) metastase.
ā. Other malignancies within 3 years prior to randomization.
ā. Clinically significant abnormalities found on resting electrocardiogram (ECG)