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| Name | Class |
|---|---|
| Zai Lab (US) LLC | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | ZL-1310 as a single agent |
|
| Arm 2 | Active Comparator | Investigator's Choice of Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-1310 | Drug | ZL-1310 as a single-agent |
| |
| Investigator's Choice of Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 27 months | |
| Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 27 months | |
| Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZL-1310-003 Study Team | Contact | (510)-316-3502 | study-ZL-1310-003@zailaboratory.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zai Lab Site 02050 | Recruiting | La Jolla | California | 92093 | United States | |
| Zai Lab Site 02033 |
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| Drug |
Topotecan, Lurbinectedin, or Amrubicin |
|
| up to 27 months |
| Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 27 months |
| Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 27 months |
| Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 27 months |
| Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 27 months |
| Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EQ-5D-5L | up to 27 months |
| Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-C30 | up to 27 months |
| Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-LC13 | up to 27 months |
| Recruiting |
| Sacramento |
| California |
| 95817 |
| United States |
| Zai Lab Site 02037 | Recruiting | Aurora | Colorado | 80045 | United States |
| Zai Lab Site 02030 | Recruiting | New Haven | Connecticut | 06519 | United States |
| Zai Lab Site 02045 | Recruiting | Clermont | Florida | 34711 | United States |
| Zai Lab Site 02031 | Recruiting | Orange City | Florida | 32763 | United States |
| Zai Lab Site 02020 | Recruiting | Rockledge | Florida | 32955 | United States |
| Zai Lab Site 02026 | Recruiting | Sarasota | Florida | 34232 | United States |
| Zai Lab Site 02052 | Recruiting | St. Petersburg | Florida | 33701-4553 | United States |
| Zai Lab Site 02047 | Recruiting | Tampa | Florida | 33612 | United States |
| Zai Lab Site 02051 | Recruiting | West Palm Beach | Florida | 33401 | United States |
| Zai Lab Site 02021 | Recruiting | Peoria | Illinois | 61615 | United States |
| Zai Lab Site 02049 | Recruiting | Peoria | Illinois | 61637 | United States |
| Zai Lab Site 02038 | Recruiting | Iowa City | Iowa | 52242 | United States |
| Zai Lab Site 02041 | Recruiting | Louisville | Kentucky | 40202 | United States |
| Zai Lab Site 02003 | Recruiting | Bethesda | Maryland | 20817 | United States |
| Zai Lab Site 02022 | Recruiting | Silver Spring | Maryland | 20904 | United States |
| Zai Lab Site 02010 | Recruiting | Detroit | Michigan | 48202 | United States |
| Zai Lab Site 02023 | Recruiting | Columbia | Missouri | 65201 | United States |
| Zai Lab Site 02009 | Recruiting | St Louis | Missouri | 63128 | United States |
| Zai Lab Site 02040 | Recruiting | The Bronx | New York | 10461 | United States |
| Zai Lab Site 02024 | Recruiting | Cleveland | Ohio | 44106 | United States |
| Zai Lab Site 02035 | Recruiting | Broomall | Pennsylvania | 19008 | United States |
| Zai Lab Site 02019 | Recruiting | Media | Pennsylvania | 19063 | United States |
| Zai Lab Site 02008 | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
| Zai Lab Site 02029 | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| Zai Lab Site 02036 | Recruiting | Nashville | Tennessee | 37203 | United States |
| Zai Lab Site 02025 | Recruiting | Austin | Texas | 78745 | United States |
| Zai Lab Site 02046 | Recruiting | Dallas | Texas | 75390-9020 | United States |
| Zai Lab Site 02025 | Recruiting | Odessa | Texas | 79761 | United States |
| Zai Lab Site 02006 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Zai Lab Site 01002 | Recruiting | Hefei | Anhui | 230036 | China |
| Zai Lab Site 01014 | Recruiting | Xiamen | Fujian | 361000 | China |
| Zai Lab Site 01001 | Recruiting | Guangzhou | Guangdong | 510080 | China |
| Zai Lab Site 01011 | Recruiting | Naning | Guangxi | 530021 | China |
| Zai Lab Site 01022 | Recruiting | Heilongjiang | Harbin | 000000 | China |
| Zai Lab Site 01008 | Recruiting | Shijiazhuang | Hebei | China |
| Zai Lab Site 01010 | Recruiting | Zhengzhou | Henan | 450052 | China |
| Zai Lab Site 01034 | Recruiting | Wuhan | Hubei | 430079 | China |
| Zai Lab Site 01012 | Recruiting | Nanjing | Jiangsu | China |
| Zai Lab Site 01015 | Recruiting | Nanchang | Jiangxi | 330029 | China |
| Zai Lab Site 01009 | Recruiting | Xi'an | Shaanxi | 710061 | China |
| Zai Lab Site 01007 | Recruiting | Jinan | Shandong | 250117 | China |
| Zai Lab Site 01005 | Recruiting | Linyi | Shandong | 276000 | China |
| Zai Lab Site 01043 | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| Zai Lab SIte 01026 | Recruiting | Chengdu | Sichuan | 610041 | China |
| Zai Lab Site 01017 | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| Zai Lab Site 01016 | Recruiting | Taizhou | Zhejiang | 318000 | China |
| Zai Lab Site 01004 | Recruiting | Beijing | 100142 | China |
| Zai Lab Site 10019 | Recruiting | Kurume | Fukuoka | 830-0011 | Japan |
| Zai Lab Site 10009 | Recruiting | Yokohama | Kanagawa | 241-8515 | Japan |
| Zai Lab Site 10015 | Recruiting | Kashihara | Nara | 634-8522 | Japan |
| Zai Lab Site 10011 | Recruiting | Hirakata | Osaka | 573-1191 | Japan |
| Zai Lab Site 10014 | Recruiting | Izumi | Osaka | 594-0073 | Japan |
| Zai Lab Site 10012 | Recruiting | Sakai | Osaka | 591-8555 | Japan |
| Zai Lab Site 10010 | Recruiting | Shizuoka | Sunto-gun | 411-8777 | Japan |
| Zai Lab Site 10003 | Recruiting | Shimosuga | Tochigi | 321-0293 | Japan |
| Zai Lab Site 10008 | Recruiting | Bunkyō-Ku | Tokyo | 113-8603 | Japan |
| Zai Lab Site 10006 | Recruiting | Bunkyō-Ku | Tokyo | 113-8677 | Japan |
| Zai Lab Site 10005 | Recruiting | Koto-Ku | Tokyo | 135-8550 | Japan |
| Zai Lab Site 10007 | Recruiting | Shinjuku-Ku | Tokyo | 162-8655 | Japan |
| Zai Lab Site 10018 | Recruiting | Fukuoka | 810-8563 | Japan |
| Zai Lab Site 10017 | Recruiting | Fukuoka | 812-8582 | Japan |
| Zai Lab Site 10016 | Recruiting | Hiroshima | 734-8551 | Japan |
| Zai Lab Site 10013 | Recruiting | Osaka | 541-8567 | Japan |
| Zai Lab Site 21003 | Recruiting | London | Greater London | W1G 6AD | United Kingdom |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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