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| Name | Class |
|---|---|
| Zhengzhou University | OTHER |
| Hunan Cancer Hospital - the Affiliated Cancer Hospital of Xiangya school of Medicine, Central South University | UNKNOWN |
| Taizhou Hospital | OTHER |
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This is a prospective, multi-cohort, single-arm Phase II clinical trial evaluating the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR non-classical mutations.
The study comprises two independent cohorts:
Cohort 1: Patients with EGFR uncommon mutations (G719X, L861Q, or S768I). Cohort 2: Patients with EGFR exon 20 insertion mutation
Primary endpoint: Objective response rate (ORR) assessed by RECIST 1.1. Secondary endpoints: Disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile (CTCAE v4.03).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G719X, L861Q, or S768I) | Experimental | Patients with EGFR uncommon mutations (G719X, L861Q, or S768I) |
|
| exon 20 insertion | Experimental | Patients with EGFR exon 20 insertion mutations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| befotertinib | Drug | Befotertinib will be administered orally at an initial dose of 75 mg once daily for 21 days, with escalation to 100 mg if tolerated. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by RECIST 1.1. | From enrollment until treatment discontinuation (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | From first dose to disease progression or death (assessed up to 36 months) | |
| Disease control rate (DCR) | From enrollment until treatment discontinuation (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Yang | Contact | +86 18868439669 | yxia@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Wen, Prof. | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Xia Yang, Prof. | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| West China Hospital |
| OTHER |
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| duration of response (DoR) | From the first documented response to disease progression or death, whichever occurs first, assessed up to 36 months. |
| overall survival（OS） | From enrollment until death from any cause, assessed up to 60 months. Survivors will be censored at the last follow-up |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |