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To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.
This study is a single arm study to access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunvozertinib combined with chemotherapy (Pemetrexed +platinum) | Experimental | Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunvozertinib | Drug | Sunvozertinib 200mg Quaquedie (QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | To assess sunvozertinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR) | Time from first dose to last dose, or up to 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death | Time from first subject dose to study completion, or up to 36 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Li, BA | Contact | 113880343287 | +86 | tracy.li_2010@hotmail.com |
| Feifei Na, MD | Contact | 18583988151 | +86 | nafeifei@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| You Lu, MD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610044 | 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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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Chemotherapy | Drug | Pemetrexed +platinum |
|
| Progression-free survival (PFS) |
To assess progression-free survival of patients treated by sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause |
| Time from first subject dose to study completion, or up to 36 month |
| Overall survival (OS) | To assess overall survival, define as first dose to the death of the subject due to any cause | Time from first subject dose to study completion, or up to 36 month |
| Adverse events (AEs) according to CTCAE 5.0 | Number of participants with adverse events (AEs) according to CTCAE 5.0 | From first dose until 28 days after the last dose, up to 24 month |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |