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| Name | Class |
|---|---|
| Dizal (Jiangsu) Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sunvozertinib | Experimental | Patients will receive neoadjuvant sunvozertinib for 12 weeks, and continue adjuvant sunvozertinib after surgery until disease relapse, unacceptable toxicity, or the end of 2-years adjuvant treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunvozertinib | Drug | Neoadjuvant stage: 300mg for 12 weeks Adjuvant stage: 300mg for first 4 weeks, then 150mg for up to 2 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) of neoadjuvant therapy | Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1 | From enrollment to the end of neoadjuvant therapy at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) | Pathological detection within 1month after surgery | |
| Pathological complete response (pCR) | Pathological detection within 1 month after surgery | |
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Inclusion Criteria:
Patients must understand the requirements and content of the clinical trial and provide a handwritten signed and dated informed consent.
Age ≥ 18 years old.
Non-small cell lung cancer confirmed by histopathology or cytology, clinical stage II, IIIA or IIIB (N2) assessed by the investigator according to AJCC 8th edition.
EGFR exon 20 insertion mutation confirmed by an approved local laboratory.
No disease progression in the past two weeks of signing the informed consent form and a score of 0-1 according to the ECOG criteria, and no significant progression within 2 weeks before the first dose.
At least one measurable target lesion according to RECIST v1.1.
Adequate bone marrow and other organ reserve:
Male patients who wish to have children should use barrier contraception (such as condoms) during the clinical trial period and 6 months after the last dose. Male patients should not donate sperm during the clinical trial period and 6 months after the last dose.
Female patients should take contraceptive measures from the start of screening to the 6 weeks after last dose, should not breastfeed, and should have a negative pregnancy test (blood or urine β-human chorionic gonadotropin) at screening.
Exclusion Criteria:
Patients who have received the following treatments must be excluded:
A history of other malignant tumors other than lung cancer within 2 years (except for basal cell carcinoma of the skin or in situ cervical cancer that has been adequately treated and has no evidence of recurrence during the screening period).
Before the first dose, there are adverse events of CTCAE > 1 grade (except for any degree of alopecia) caused by previous treatment (such as diagnostic puncture, use of other drugs, etc.).
History of stroke or intracranial hemorrhage within 6 months before the first dose.
According to the investigator's judgment, the presence of any severe or poorly controlled systemic disease, including any of the following poorly controlled heart-related diseases or abnormalities:
Patients with a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone treatment, or any clinically active interstitial lung disease, or immune pneumonitis caused by immunotherapy.
Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, difficulty in swallowing medication, or previous intestinal resection that prevents adequate absorption of sunvozertinib.
Women who are breastfeeding or pregnant.
Patients who are allergic to the drug components of sunvozertinib.
Patients who are assessed by the investigator as being unable to undergo clinical trials, unable to tolerate surgery, or who may lack compliance with clinical trials should not participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolong Yan | Contact | +86 15991269383 | yanxiaolong@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | China |
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| Downstaging rate of N2 lymph nodes |
| From enrollment to the end of neoadjuvant therapy at 12 weeks |
| Disease control rate (DCR) of neoadjuvant therapy | From enrollment to the end of neoadjuvant therapy at 12 weeks |
| Event free survival (EFS) | From date of enrollment until the date of first documented disease progression, relapse, or death due to any cause progression, whichever came first, assessed up to 60 months |
| Disease free survival (DFS) | From date of surgical resection until the date of first documented disease relapse or death due to any cause , whichever came first, assessed up to 56 months |
| Overall survival (OS) | From date of enrollment until the date of death due to any cause , assessed up to 84 months |
| Adverse events | From date of enrollment until the end of the study, assessed up to 36 months |
| General Hospital of Ningxia Medical University | Not yet recruiting | Yinchuan | Ningxia | China |
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| Tangdu Hospital | Recruiting | Xi'an | Shaanxi | China |
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