Actively Recruiting
A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery
Led by Dizal (Jiangsu) Pharmaceutical Co., Ltd. · Updated on 2025-12-15
360
Participants Needed
49
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the efficacy and safety of sunvozertinib versus placebo as adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) or P-loop and αC-helix compression (PACC) mutations, who have had radical surgery, regardless of adjuvant chemotherapy.
CONDITIONS
Official Title
A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide a signed and dated informed consent form before any study procedures
- Be at least 18 years old at the time of consent
- Have had complete surgical removal (R0) of primary NSCLC tumor confirmed by histology
- NSCLC must be stage IB, II, or IIIA according to AJCC TNM 9.0 edition post-surgery
- Have documented EGFR exon 20 insertion or PACC mutations from a certified laboratory
- Provide sufficient tumor tissue samples for mutation confirmation
- Have ECOG performance status of 0 or 1
- Be recovered from prior lung surgery and systemic therapy without Grade 1 or higher adverse events except alopecia and limited neuropathy
- If no prior adjuvant chemotherapy, randomize between 4 to 10 weeks after surgery
- If prior adjuvant chemotherapy, randomize 2 to 10 weeks after finishing chemotherapy and no more than 26 weeks after surgery
- Have adequate bone marrow and organ function within 7 days before randomization
- Male participants with female partners of child-bearing potential must use barrier contraception and avoid sperm donation during and 6 months after treatment
- Female participants of child-bearing potential must use reliable contraception during study and for 2 months after stopping study drug, not breastfeed, and have a negative pregnancy test or meet post-menopausal or sterilization criteria
You will not qualify if you...
- Have concurrent EGFR sensitizing mutations like L858R or exon 19 deletion, or other driver gene variations with available therapies
- Have only had segmentectomies or wedge resections
- Have received preoperative or postoperative radiotherapy for NSCLC or plan to receive radiotherapy during the study
- Have received any EGFR TKIs as neoadjuvant or adjuvant therapy for NSCLC or have known complete pathological response from neoadjuvant therapy
- Are taking or unable to stop medications or herbs that strongly induce CYP3A within 2 weeks before randomization
- Have a history of interstitial lung disease, drug-induced ILD, radiation pneumonitis requiring steroids, active ILD, or immunotherapy-induced pneumonitis
- Have serious or uncontrolled systemic diseases requiring treatment, active infections including hepatitis B, C, or HIV
- Have certain cardiac abnormalities including prolonged QTc >470 msec, significant ECG abnormalities, or recent atrial fibrillation
- Have a history of any malignancy except adequately treated non-melanoma skin cancer, carcinoma in situ, or other solid tumors with over 5 years since treatment and no recurrence
- Have refractory nausea/vomiting, chronic GI disease, inability to swallow study drug, or major bowel resection affecting drug absorption
- Are hypersensitive to sunvozertinib, its excipients, or similar drugs
- Are involved in the study design, planning, or conduct
- Are judged unlikely to comply with study procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
Beijing Cancer Hospital
Beijing, China
Not Yet Recruiting
2
Beijing Chest Hospital, Capital medical university
Beijing, China
Not Yet Recruiting
3
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Not Yet Recruiting
4
China-Japan Friendship hospital
Beijing, China
Not Yet Recruiting
5
Peking Union Medical College Hospital
Beijing, China
Not Yet Recruiting
6
Xuanwu Hospital Capital Medical University
Beijing, China
Not Yet Recruiting
7
The First Hospital of Jilin University
Changchun, China
Actively Recruiting
8
Hunan Cancer Hospital
Changsha, China
Not Yet Recruiting
9
The Third Xiangya Hospital of Central South University
Changsha, China
Not Yet Recruiting
10
Xiangya Hospital of Central South University
Changsha, China
Not Yet Recruiting
11
Sichuan Cancer Hospital
Chengdu, China
Not Yet Recruiting
12
West China Hospital Sichuan University
Chengdu, China
Not Yet Recruiting
13
Fujian Cancer Hospital
Fuzhou, China
Not Yet Recruiting
14
Fujian Medical University Union Hospital
Fuzhou, China
Not Yet Recruiting
15
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, China
Not Yet Recruiting
16
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Not Yet Recruiting
17
Sun Yat-sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
18
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Not Yet Recruiting
19
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
20
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
21
Zhejiang Cancer Hospital
Hangzhou, China
Not Yet Recruiting
22
Harbin Medical University Cancer Hospital
Harbin, China
Not Yet Recruiting
23
Anhui Provincial Cancer Hospital
Hefei, China
Actively Recruiting
24
Jinan Central Hospital
Jinan, China
Not Yet Recruiting
25
Shandong Cancer Hospital
Jinan, China
Actively Recruiting
26
Yunnan Cancer Hospital
Kunming, China
Not Yet Recruiting
27
Jiangxi Provincial People 's Hospital
Nanchang, China
Not Yet Recruiting
28
Jiangsu Province Hospital
Nanjing, China
Not Yet Recruiting
29
Nanjing Chest Hospital
Nanjing, China
Not Yet Recruiting
30
Guangxi Medical University Cancer Hospital
Nanning, China
Not Yet Recruiting
31
Fudan University Shanghai Cancer Center
Shanghai, China
Not Yet Recruiting
32
Shanghai Chest Hospital
Shanghai, China
Not Yet Recruiting
33
Shanghai East Hospital
Shanghai, China
Not Yet Recruiting
34
Shanghai Pulmonary Hospital
Shanghai, China
Actively Recruiting
35
Zhongshan Hospital Fudan University
Shanghai, China
Not Yet Recruiting
36
Liaoning Cancer Hospital & Institute
Shenyang, China
Not Yet Recruiting
37
The First Hospital of China Medical University
Shenyang, China
Not Yet Recruiting
38
Shanxi Cancer hospital (Shanxi Cancer institute)
Taiyuan, China
Not Yet Recruiting
39
Shanxi Provincial people's hospital
Taiyuan, China
Not Yet Recruiting
40
Taizhou Hospital, Zhejiang Province
Taizhou, China
Not Yet Recruiting
41
Tianjin Chest Hospital
Tianjin, China
Not Yet Recruiting
42
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Not Yet Recruiting
43
Tianjin Medical University General Hospital
Tianjin, China
Not Yet Recruiting
44
Hubei Cancer Hospital
Wuhan, China
Not Yet Recruiting
45
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Not Yet Recruiting
46
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Not Yet Recruiting
47
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Not Yet Recruiting
48
Henan Cancer Hospital
Zhengzhou, China
Not Yet Recruiting
49
The first affiliated hospital of Zhengzhou University
Zhengzhou, China
Not Yet Recruiting
Research Team
S
Sherry Hu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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