NCT07459634 · Jazz Pharmaceuticals
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
What this study is about
The purpose of this study is to evaluate the effectiveness and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.
View original scientific description
The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.
Interventions
DRUG
Lurbinectedin
Administered by intravenous (IV) infusion
DRUG
Durvalumab
Administered by intravenous (IV) infusion
Primary outcome measures
Investigator assessed PFS rate
Time frame: 6 months
Progression Free Survival (PFS) rate is the proportion of participants who have not experienced disease progression (as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) or death from any cause
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).
- Participant has received 4 cycles of definitive platinum-based chemotherapy with durvalumab
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
- Adequate hematologic and end-organ function for at least 7 days prior to dosing.
- Has a body weight \> 30 kg.
- Adequate contraceptive precautions.
Exclusion criteria
- History of leptomeningeal carcinomatosis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- History of another primary malignancy
- Presence or history of Central Nervous System (CNS) metastases
- History of allogeneic organ transplantation.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.
- Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
- Concurrent enrollment in another clinical study
- Prior enrollment or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
- Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.
Where
- Los Angeles, California
- Jacksonville, Florida
- Atlanta, Georgia
- Rock Hill, South Carolina
Collaborators
Jazz Pharmaceuticals Ireland Limited
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations