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To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.
A phase IV, prospective, single arm, multi-center, observational study to collect safety and outcome data of Zepzelca in adult participants with extensive stage SCLC previously exposed to at least one line of treatment with platinum-based chemotherapy. Patients enrolled in the study will be encouraged to complete patient reported outcome (PRO) questionnaires.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zepzelca | Drug | Zepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | up to 6 months after first infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | up to 6 months after first infusion | |
| Progression-Free Survival (PFS) | up to 6 months after first infusion | |
| Duration of Response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with extensive SCLC treated with Zepzelca.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States | ||
| Eastern Connecticut Hematology and Oncology |
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| up to 6 months after first infusion |
| Disease Control Rate (DCR) | up to 6 months after first infusion |
| Distribution of Treatment Patterns in Participants Measured by Number of Days in a Cycle, Dose Intensity, Number of Dose Reductions and Dose Delays, Number of Cycles Summarized by Number of Previous Lines of Therapy | up to 6 months after first infusion |
| Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | up to 6 months after first infusion |
| Time to Response to Zepzelca | up to 6 months after first infusion |
| Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires | up to 6 months after first infusion |
| Overall Survival (OS) in Other Subgroups of Interest | up to 6 months after first infusion |
| Progression-Free Survival (PFS) in Other Subgroups of Interest | up to 6 months after first infusion |
| Duration of Response (DoR) in Other Subgroups of Interest | up to 6 months after first infusion |
| Disease Control Rate (DCR) in Other Subgroups of Interest | up to 6 months after first infusion |
| Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest | up to 6 months after first infusion |
| Norwich |
| Connecticut |
| 06360 |
| United States |
| ASCLEPES Research Centers | Brooksville | Florida | 34613 | United States |
| Woodlands Medical Specialists - Woodlands Center For Specialized Medicine | Pensacola | Florida | 32503 | United States |
| Mid-Illinois Hematology & Oncology Associates | Normal | Illinois | 61761 | United States |
| Goshen Health Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| Siouxland Regional Cancer Center dba June E. Nylen Cancer Center | Sioux City | Iowa | 51101 | United States |
| Stormont-Vail Cancer Center-Stormont-Vail Healthcare - Cotton-O'Neil Cancer Center | Topeka | Kansas | 66606 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Pikeville Medical Center - Leonard Lawson Cancer Center | Pikeville | Kentucky | 41501 | United States |
| West Jefferson Cancer Center | Marrero | Louisiana | 70072 | United States |
| MMCORC - HealthPartners Institute | Saint Louis Park | Minnesota | 55416 | United States |
| Singing River Health System | Pascagoula | Mississippi | 39581 | United States |
| Central Care Cancer Center | Bolivar | Missouri | 65613 | United States |
| Benefis Medical Group | Great Falls | Montana | 59405 | United States |
| Regional Cancer Care Associates LLC (RCCA) | Hackensack | New Jersey | 07601 | United States |
| Center for Clinical Research-Rochester General Hospital | Rochester | New York | 14625 | United States |
| Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP) | The Bronx | New York | 10461 | United States |
| University of North Carolina NASH Cancer Center | Rocky Mount | North Carolina | 27804 | United States |
| Trinity Cancercare Center | Minot | North Dakota | 58701 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| Tri-County Hematology & Oncology Associates, Inc | Massillon | Ohio | 44646 | United States |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | United States |
| Charleston Hematology Oncology Associates, PA | Charleston | South Carolina | 29414 | United States |
| Carolina Blood & Cancer Care Associates | Rock Hill | South Carolina | 29732 | United States |
| Lexington Oncology Associates | West Columbia | South Carolina | 29169 | United States |
| Monument Health Cancer Care Institute | Rapid City | South Dakota | 57701 | United States |
| Baptist Cancer Center | Memphis | Tennessee | 38120 | United States |
| Baylor Scott & White Medical Center - Temple | Temple | Texas | 76508 | United States |
| Tranquil Clinical Research | Webster | Texas | 77598 | United States |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | United States |
| Cape Breton Cancer Centre | Sydney | Nova Scotia | B1P 1P3 | Canada |
| Southlake Regional Health Centre (York County Hospital) | Newmarket | Ontario | L3Y 2P9 | Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Centre integre de sante et de services sociaux de Chaudiere-Appalaches | Lévis | Quebec | G6V 3Z1 | Canada |
| Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk | Rimouski | Quebec | G5L 5T1 | Canada |
| Universite Laval - Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) (Hopital Laval) | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| CIUSSS de L'Estrie - CHUS - Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| 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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| ID | Term |
|---|---|
| C568606 | PM 01183 |
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