Clincosm LogoSign in Get a demo

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

Sponsor
Jazz Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04894591
Collaborator
(none)
300
Enrollment
37
Locations
35.1
Anticipated Duration (Months)
8.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
EMERGE 402: Phase IV Observational Study to Collect Safety and Outcome Data in Real-World Setting in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Zepzelca
Actual Study Start Date :
Jun 28, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Overall Response Rate (ORR) [up to 24 months after first infusion]

Secondary Outcome Measures

  1. Overall Survival (OS) [up to 24 months after first infusion]

  2. Progression-Free Survival (PFS) [up to 24 months after first infusion]

  3. Duration of Response (DoR) [up to 24 months after first infusion]

  4. Disease Control Rate (DCR) [up to 24 months after first infusion]

  5. 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 24 months after first infusion]

  6. 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 24 months after first infusion]

  7. Time to Response to Zepzelca [up to 24 months after first infusion]

  8. Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires [up to 24 months after first infusion]

  9. Overall Survival (OS) in Other Subgroups of Interest [up to 24 months after first infusion]

  10. Progression-Free Survival (PFS) in Other Subgroups of Interest [up to 24 months after first infusion]

  11. Duration of Response (DoR) in Other Subgroups of Interest [up to 24 months after first infusion]

  12. Disease Control Rate (DCR) in Other Subgroups of Interest [up to 24 months after first infusion]

  13. Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest [up to 24 months after first infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oncology Specialties PC Huntsville Alabama United States 35805
2 Pacific Cancer Medical Center, Inc Anaheim California United States 92801
3 Eastern Connecticut Hematology And Oncology Norwich Connecticut United States 06360
4 ASCLEPES Research Centers Brooksville Florida United States 34613
5 Woodlands Medical Specialists - Woodlands Center For Specialized Medicine Pensacola Florida United States 32503
6 Rural Reach Research dba 3R Boise Idaho United States 83709
7 Mid-Illinois Hematology & Oncology Associates, Ltd. Normal Illinois United States 61761
8 Goshen Center for Cancer Care Goshen Indiana United States 46526
9 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
10 Central Care Cancer Center Garden City Kansas United States 67846
11 Stormont Vail Cancer Center - Stormont Vail Healthcare - Cotton-O´Neil Cancer Center Topeka Kansas United States 66606
12 Cancer Center of Kansas Wichita Kansas United States 67214
13 Baptist Health Lexington Lexington Kentucky United States 40503
14 Pikeville Medical Center Pineville Kentucky United States 41501
15 West Jefferson Medical Center Cancer Center Marrero Louisiana United States 70072
16 Michigan Center of Medical Research Farmington Hills Michigan United States 48334
17 Singing River Health System Pascagoula Mississippi United States 39581
18 Central Care Cancer Center Bolivar Missouri United States 65613
19 Benefis Sletten Cancer Institute Great Falls Montana United States 59404
20 Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska United States 68310
21 Regional Cancer Care Associates LLC Hackensack New Jersey United States 07601
22 Regional Care Cancer Associates LLC Little Silver New Jersey United States 07739
23 Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP) Bronx New York United States 10461
24 Rochester General Hospital Lipson Cancer Institute Rochester New York United States 14621
25 Marion L. Shepard Cancer Center Washington North Carolina United States 27889
26 Trinity Health - Trinity Cancercare Center Minot North Dakota United States 58701
27 Gabrail Cancer Center Research Canton Ohio United States 44718
28 Tri-County Hematology and Oncology Associate, Inc. Massillon Ohio United States 44646
29 27889 Wynnewood Pennsylvania United States 19096
30 Charleston Oncology Charleston South Carolina United States 29414
31 Carolina Blood and Cancer Care Associates, PA Rock Hill South Carolina United States 29732
32 Lexington Oncology Associates West Columbia South Carolina United States 29169
33 Monument Health Cancer Care Institute Rapid City South Dakota United States 57701
34 Baptist Cancer Center Memphis Tennessee United States 38120
35 Research Institute & Clinical Alliance Houston Texas United States 77089
36 Renovatio Clinical The Woodlands Texas United States 77380
37 Tranquil Clinical Research Webster Texas United States 77598

Sponsors and Collaborators

  • Jazz Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04894591
Other Study ID Numbers:
  • JZP712-402
First Posted:
May 20, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma

Study Results

No Results Posted as of Aug 24, 2022