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This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WX-0593 | Experimental | The treatment will be administrated as neoadjuvant 8 weeks before surgery. After surgical intervention the treatment will be administered up to 2 years. Treatment will be discontinued in case of unacceptable toxicity or disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WX-0593 Tablets | Drug | 60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 28-days cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathologic Response (MPR) Rate | Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) Rate | Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of residual tumor in lung and lymph nodes. | At time of surgery |
| Resectability rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pingping Song | Contact | 18663776711 | SPP128@126.com | |
| Guodong Zhang | Contact | 15701206264 | zzkzgd@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital and Institute | Recruiting | Jinan | Shandong | 250117 | 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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Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.
| At time of surgery |
| R0 Resection rate | R0 Resection rate is defined as the percentage of participants who were able to undergo R0 Resection surgery after neoadjuvant therapy. | At time of surgery |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the percentage of participants who have a complete response (CR) or partial response (PR). Responses are according to RECIST 1.1 as assessed by investigator. | Prior to surgery |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD). Responses are according to RECIST 1.1 as assessed by investigator. | Prior to surgery |
| Event-free survival (EFS) | Event-free survival (EFS) is the length of time after initial administration the participant remains free of recurrence/progression or death, whatever the cause. | 3 years postoperatively |
| Disease-free survival (DFS) | Disease-free survival (DFS) is the length of time after surgical resection the participant remains free of recurrence/progression or death, whatever the cause. | 3 years postoperatively |
| Overall Survival (OS) | Overall Survival (OS) is the length of time after initial administration the participant remains alive. | 3 years postoperatively |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |