A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal G… (NCT06670196) | Clinical Trial Compass
Active — Not 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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged ≥18 years to ≤75 years at the time of signing the informed consent form (ICF), regardless of gender.
. 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.
. No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
. Histologically or cytologically confirmed EGFR-sensitive mutations.
. Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible.
. At least one target lesion assessed by the investigator based on RECIST v1.1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: Randomization up to approximately 36 months
. ECOG performance status score of 0 or 1 within 7 days prior to randomization.
. Life expectancy ≥ 12 weeks.
Exclusion criteria
. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%.
. Subjects who have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
. Subjects who have received any of the following therapies (including the adjuvant/neoadjuvant therapy):
. Targeted TROP2 therapy;
. Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or central nervous system (CNS) metastase.
. Other malignancies within 3 years prior to randomization.
. Clinically significant abnormalities found on resting electrocardiogram (ECG)