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The aim of this trial is to evaluate the safety of WX-0593 combined with concurrent chemoradiotherapy in unresectable, locally advanced non-small cell lung cancer (NSCLC) with activating mutation of ALK or ROS1. This trial consists of two parts. In Part 1, approximately 8 patients will be included and receive WX-0593 maintenance until disease progression or unacceptable toxicity. In Part 2, approximately 32 patients will be included and receive WX-0593 monotherapy for 1-2 cycles and subsequently with concurrent chemoradiation, followed by WX-0593 maintenance until disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WX-0593 single arm | Experimental | Part 1: Participants will receive WX-0593 monotherapy until disease progression or unacceptable toxicity. Part 2: Participants will receive 1 or 2 cycles of WX-0593 monotherapy and subsequently with concurrent chemoradiation, followed by WX-0593 monotherapy until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WX-0593 Tablets | Drug | WX-0593 60 mg, tablets, orally, once daily for 7 days, followed by WX-0593 180 mg, tablets, orally, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis | within 90 days after radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time from the first dose of study drug to the first documented disease progression or death due to any cause, whichever occurs first | 24 months |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
Has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinming Yu, PhD | Contact | 8613806406293 | jn7984729@public.jn.sd.cn | |
| Linlin Wang, PhD | Contact | 8613793187739 | wanglinlinatjn@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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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| chemotherapy | Drug | Platinum-based chemotherapy |
|
| Thoracic Radiation Therapy(TRT) | Radiation | Five days a week to accept chest radiotherapy, once per day, every time 1.8-2.0 Gy, total dose 54-66 Gy |
|
OS is defined as the time from the first dose of study drug to death due to any cause.
| 24 months |
| Adverse Events (AEs) | Percentage of participants who experienced one or more AEs. | 24 months |
| Disease control rate (DCR) | 24 months |
| Objective response rate (ORR) | 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |