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The study will evaluate the efficacy and safety of treatment with sunvozertinib in combination with Anlotinib in patients whose disease has progressed following first-line EGFR-TKIs treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sunvozertinib in combination with Anlotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunvozertinib combination with Anlotinib | Drug | Sunvozertinib 300 mg once daily (QD) with Anlotinib 12mg once daily (QD in Day 1-14) ,21 days in one cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria. | initiate from first dose until the date of confirmed response, assessed up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS as assessed by the investigator according to RECIST 1.1 | initiate from first dose, every 6 weeks until PD or study close, an average of 1 year |
| OS | initiate from first dose to death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
Any known RET rearrangement, BRAF V600E mutation, NTRK fusion, MET ex14 skip mutation, MET amplification (defined as tissue detection GCN ≥ 5 by NGS)
Any concurrent and/or other active malignancy within 2 years
Major surgery within 4 weeks of the first dose of IP
Any unresolved toxicities from prior therapy.
Past medical history of ILD (interstitial lung disease)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis
Any evidence of severe or uncontrolled systemic diseases.
Any of the following cardiac criteria:
i) Mean resting QTc >470 msec ii) Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of Sunvozertinib and Anlotinib
Severe allergies to Sunvozertinib and Anlotinib
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| through study completion, an average of 1.5 years |
| DoR | The period from the first judgment of CR or PR to PD | an average of 1 year |
| AE | TRAE as assessed by the investigator according to CTCAE 5.0 | through study completion, an average of 1 year |