A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Anti-Tumor Efficacy and Safety of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery (WU-KONG16)

Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Provide a signed and dated informed consent form (ICF) prior to any study specific procedures, sampling, and analyses.

• Aged at least 18 years old at the time of ICF signature.

• Complete resection (R0) of the primary tumor and histologically confirmed diagnosis of NSCLC (participants with tumor histology indicative of neuroendocrine carcinoma, sarcomatoid carcinoma, or small cell lung cancer should be excluded).

‣ Complete surgical resection of the primary NSCLC is mandatory. All gross lesions must be completely resected to achieve microscopically negative margins. Hilar and mediastinal lymph node dissection should be performed per clinical guidelines.

⁃ Acceptable surgery type: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.

⁃ Acceptable surgery approach: thoracotomy or thoracoscopic surgery.

• Participants must have NSCLC classified post-operatively as stage IB, II, or IIIA according to the AJCC TNM staging 9.0th edition.

• Have documented EGFR exon20ins (Cohort 1) or EGFR PACC mutations (Cohort 2) from a local Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (or equivalent).

• • Common EGFR PACC mutations include, but not limited to, L718Q, G719X, S768I, L747P/S, V769L, E709\_T710delinsD, L792H, and T854I.

• Participants must provide sufficient tumor tissue samples for confirmation of EGFR mutations by the sponsor designated central laboratory.

• ECOG performance status is 0 or 1.

• Participants must recover from prior lung surgery and systemic therapy (e.g., neoadjuvant therapy and/or adjuvant chemotherapy) without Grade 1 or higher AEs (except alopecia of any grade and ≤ Grade 2 platinum-associated neuropathy) at randomization.

‣ Participants who have not previously received adjuvant chemotherapy should be randomized as early as 4 weeks and within 10 weeks after the radical surgery.

⁃ Participants who have previously received adjuvant chemotherapy can be randomized within 2 - 10 weeks of completion of adjuvant chemotherapy with a maximum interval of no more than 26 weeks from surgery to randomization. The adjuvant chemotherapy can start as early as 4 weeks after the radical surgery, in 21-day cycles, and up to 4 cycles.

• Adequate bone marrow reservation or organ functions within 7 days prior to randomization.

⁃ Male participants with female partners of child-bearing potential should use barrier contraceptives (e.g., by use of condoms), during their participation in this study and for 6 months following the last dose of the study drug. Male participants must refrain from donating sperm during their participation in the study and for 6 months following the last dose of the study drug. If male participants wish to father children, they should be advised to arrange for freezing of sperm samples prior to the start of study drug.

⁃ Female participants of child-bearing potential should use reliable contraceptives from the time of screening until 2 months after discontinuation of study drug. Female participants should not be breast feeding and must have a negative pregnancy test (serum or urine β-human chorionic gonadotropin) prior to start dosing or must fulfil one of the following criteria at screening:

∙ Post-menopausal defined as aged at least 50 years old and amenorrhea for at least 12 months following cessation of all exogenous hormonal treatment.

‣ Women under 50 years old would be considered postmenopausal if they have been amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range.

‣ Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

Locations
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Beijing Chest Hospital, Capital medical university
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
China-Japan Friendship hospital
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
NOT_YET_RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital Sichuan University
NOT_YET_RECRUITING
Chengdu
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Jinan Central Hospital
NOT_YET_RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Jiangxi Provincial People 's Hospital
NOT_YET_RECRUITING
Nanchang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing Chest Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Shanghai Chest Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai East Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Zhongshan Hospital Fudan University
NOT_YET_RECRUITING
Shanghai
Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITING
Shenyang
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Shanxi Cancer hospital (Shanxi Cancer institute)
NOT_YET_RECRUITING
Taiyuan
Shanxi Provincial people's hospital
NOT_YET_RECRUITING
Taiyuan
Taizhou Hospital, Zhejiang Province
NOT_YET_RECRUITING
Taizhou
Tianjin Chest Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
Hubei Cancer Hospital
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The first affiliated hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Sherry Hu, MD, PhD
sherry.hu@dizalpharma.com
+86 2161098345
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2031-01
Participants
Target number of participants: 360
Treatments
Experimental: Sunvozertinib, 200 mg orally, once daily
Placebo_comparator: Matching placebo, 200 mg orally, once daily
Sponsors
Leads: Dizal (Jiangsu) Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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