Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Inse… (NCT07274761) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.
China24 participantsStarted 2024-10-17
Plain-language summary
To assess the efficacy and safety of sunvozertinib as neoadjuvant therapy in patients with stage II-IIIB non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓.Age ≥ 18 years. 3.Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC). Assessed as resectable Stage II-III disease (per the American Joint Committee on Cancer (AJCC) 8th edition).
✓.Confirmed EGFR exon 20 insertion mutation by a validated test. 5.No evidence of disease progression within the past two weeks prior to signing informed consent and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓.Adequate hematological and organ function, as defined by: 7.Hematological: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\^9/L Platelet count ≥ 100 × 10\^9/L Hemoglobin ≥ 9 g/dL
✓.Male patients with female partners of childbearing potential must agree to use a highly effective barrier method of contraception (e.g., condom) during the trial intervention period and for 6 months after the last dose. Male patients must refrain from donating sperm during this same period.
✓.Female patients must agree to use contraception from the time of screening until 6 weeks after the last dose, must not be breastfeeding, and must have a negative pregnancy test (serum or urine beta-human chorionic gonadotropin, β-hCG) at screening.
Exclusion criteria
✕.History of other malignancies within the past 2 years (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix).
✕.History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
✕.Severe or uncontrolled systemic diseases/active infection. 5.Any severe or poorly controlled systemic disease, in the investigator's judgment, including but not limited to the following cardiac conditions or abnormalities: QT interval corrected using Fridericia's formula (QTcF) \> 470 msec at rest on electrocardiogram (ECG).
What they're measuring
1
Objective response rate (ORR)
Timeframe: up to 30 months
Trial details
NCT IDNCT07274761
SponsorShanghai Pulmonary Hospital, Shanghai, China
✕.History of interstitial lung disease (ILD), drug-induced ILD, or any evidence of ILD on imaging at screening.
✕.Refractory nausea and vomiting, chronic gastrointestinal diseases, or significant bowel resection that would preclude adequate absorption of Sunvozertinib.
✕.Women who are breastfeeding or pregnant. 9.Known hypersensitivity to the active ingredient or any excipients of Sunvozertinib.
✕0.Patients who, in the judgment of the investigator, are unsuitable for participation in this clinical trial or are unlikely to comply with the study procedures and requirements.