Lung Cancer Clinical Trial

To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

Summary

To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.
Patients initiating Zepzelca treatment in second-line.
Patients who are sensitive to platinum-based chemotherapy with CTFI≥180 days. The CTFI is defined as the length of time from last platinum dose to time of relapse or disease progression.
Eastern Cooperative Oncology Group performance status (ECOG) ≤1

Exclusion Criteria:

Patients who discontinued a prior Zepzelca treatment due to adverse events.
Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.
Patient received treatment with any investigational agent within 30 days prior to first Zepzelca infusion or plans to use another investigational agent while receiving Zepzelca.
Known CNS involvement prior to Zepzelca treatment.
Patients who were treated with Zepzelca in later lines rather than in second-line treatment

Study is for people with:

Lung Cancer

Estimated Enrollment:

300

Study ID:

NCT04894591

Recruitment Status:

Recruiting

Sponsor:

Jazz Pharmaceuticals

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There are 51 Locations for this study

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Clearview Cancer Institute
Huntsville Alabama, 35805, United States
Pacific Cancer Medical Center, Inc
Anaheim California, 92801, United States
Eastern Connecticut Hematology and Oncology
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
Rural Reach Research dba 3R
Boise Idaho, 83709, 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
Central Care Cancer Center
Garden City Kansas, 67846, 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
Michigan Center of Medical Research
Farmington Hills Michigan, 48334, 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
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha Nebraska, 68131, United States
Regional Cancer Care Associates LLC (RCCA)
Hackensack New Jersey, 07601, United States
Regional Cancre Care Associates, LLC (RCCA)
Little Silver New Jersey, 07739, United States
Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP)
Bronx New York, 10461, United States
Center for Clinical Research-Rochester General Hospital
Rochester New York, 14625, United States
University of North Carolina NASH Cancer Center
Rocky Mount North Carolina, 27804, United States
Marion L. Shepard Cancer Center
Washington North Carolina, 27889, 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
Research Institute & Clinical Alliance
Houston Texas, 77089, United States
Baylor Scott & White Medical Center - Temple
Temple Texas, 76508, United States
Renovatio Clinical - The Woodlands Research Center
The Woodlands Texas, 77380, United States
Tranquil Clinical Research
Webster Texas, 77598, United States
ThedaCare Regional Cancer Center
Appleton Wisconsin, 54911, United States
Horizon Health Network, The Moncton Hospital
Moncton New Brunswick, E1C 6, Canada
Cape Breton Cancer Centre
Sydney Nova Scotia, B1P 1, Canada
Southlake Regional Health Centre (York County Hospital)
Newmarket Ontario, L3Y 2, Canada
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi Quebec, G7H 5, Canada
Centre integre de sante et de services sociaux de Chaudiere-Appalaches
Levis Quebec, G6V 3, Canada
Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk
Rimouski Quebec, G5L 5, Canada
Universite Laval - Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) (Hopital Laval)
Sainte-Foy Quebec, G1V 4, Canada
CIUSSS de L'Estrie - CHUS - Hopital Fleurimont
Sherbrooke Quebec, J1H 5, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

300

Study ID:

NCT04894591

Recruitment Status:

Recruiting

Sponsor:


Jazz Pharmaceuticals

How clear is this clinincal trial information?

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