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.
Brief Title
To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)
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.
Completion Date
Completion Date Type
Actual
Conditions
Extensive-stage Small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
1. Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
2. Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
3. Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.
4. Patients initiating Zepzelca treatment in second-line.
5. 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.
6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1
Exclusion Criteria:
1. Patients who discontinued a prior Zepzelca treatment due to adverse events.
2. Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.
3. 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.
4. Known CNS involvement prior to Zepzelca treatment.
5. Patients who were treated with Zepzelca in later lines rather than in second-line treatment
1. Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
2. Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
3. Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.
4. Patients initiating Zepzelca treatment in second-line.
5. 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.
6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1
Exclusion Criteria:
1. Patients who discontinued a prior Zepzelca treatment due to adverse events.
2. Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.
3. 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.
4. Known CNS involvement prior to Zepzelca treatment.
5. Patients who were treated with Zepzelca in later lines rather than in second-line treatment
Inclusion Criteria
Inclusion Criteria:
1. Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
2. Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
3. Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.
4. Patients initiating Zepzelca treatment in second-line.
5. 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.
6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1
1. Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
2. Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
3. Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.
4. Patients initiating Zepzelca treatment in second-line.
5. 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.
6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04894591
Org Class
Industry
Org Full Name
Jazz Pharmaceuticals
Org Study Id
JZP712-402
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Jazz 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
Primary Outcomes
Outcome Measure
Overall Response Rate (ORR)
Outcome Time Frame
up to 6 months after first infusion
Secondary Outcomes
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Progression-Free Survival (PFS)
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Duration of Response (DoR)
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Disease Control Rate (DCR)
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
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
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Time to Response to Zepzelca
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Overall Survival (OS) in Other Subgroups of Interest
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Progression-Free Survival (PFS) in Other Subgroups of Interest
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Duration of Response (DoR) in Other Subgroups of Interest
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Disease Control Rate (DCR) in Other Subgroups of Interest
Outcome Time Frame
up to 6 months after first infusion
Outcome Measure
Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Adult participants with extensive SCLC treated with Zepzelca.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Categories Mesh Debug
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
SMALL CELL LUNG CARCINOMA
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
LUNG NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
PM 01183