Actively Recruiting
Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC
Led by Tang-Du Hospital · Updated on 2025-07-25
27
Participants Needed
3
Research Sites
223 weeks
Total Duration
On this page
Sponsors
T
Tang-Du Hospital
Lead Sponsor
D
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, phase 2 study to investigate the efficacy and safety of sunvozertinib as neoadjuvant and adjuvant treatment for stage II-IIIB non-small-cell lung cancer patients with EGFR exon20 insertion mutation.
CONDITIONS
Official Title
Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand the clinical trial and provide handwritten signed and dated informed consent.
- Age 18 years or older.
- Confirmed non-small cell lung cancer at clinical stage II, IIIA, or IIIB (N2) per AJCC 8th edition.
- EGFR exon 20 insertion mutation confirmed by an approved local laboratory.
- No disease progression in the 2 weeks before informed consent and ECOG performance status of 0-1.
- At least one measurable target lesion according to RECIST v1.1.
- Adequate bone marrow and organ function including ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL, bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN if Gilbert syndrome), ALT and AST ≤ 2.5 × ULN, creatinine ≤ 1.5 × ULN with clearance ≥ 60 mL/min, INR ≤ 1.5 × ULN, and APTT ≤ 1.5 × ULN.
- Male patients wishing to have children must use barrier contraception during the trial and for 6 months after last dose; no sperm donation during this period.
- Female patients must use contraception from screening until 6 weeks after last dose, not breastfeed, and have a negative pregnancy test at screening.
You will not qualify if you...
- Prior systemic anti-tumor treatment including radiotherapy.
- Use of other investigational drugs within 28 days without tumor assessment or without sufficient washout.
- Use of traditional Chinese medicine or drugs strongly affecting CYP3A4 without a 1-week washout.
- History of other cancers within 2 years except adequately treated basal cell carcinoma or in situ cervical cancer.
- Adverse events greater than CTCAE grade 1 from previous treatments before first dose, except alopecia.
- Stroke or intracranial hemorrhage within 6 months before first dose.
- Severe or uncontrolled systemic diseases including significant heart rhythm abnormalities, prolonged QTc interval, heart failure, or arrhythmias.
- History of interstitial lung disease or immune pneumonitis.
- Refractory nausea, vomiting, chronic gastrointestinal disease, or swallowing difficulties affecting drug absorption.
- Women who are pregnant or breastfeeding.
- Allergy to sunvozertinib components.
- Inability to tolerate surgery or comply with clinical trial requirements as assessed by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
2
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Not Yet Recruiting
3
Tangdu Hospital
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
X
Xiaolong Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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