A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Recruiting · NCT07459634 · Interventional (participants receive a specific treatment) · Lead sponsor: Jazz Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
4 locations listed across 4 US states.
- Valkyrie Clinical Trials, Inc. - Los Angeles, California, United States
- Cancer Specialists of North Florida - Jacksonville, Florida, United States
- Emory University - Atlanta, Georgia, United States
- Carolina Blood and Cancer Care - Rock Hill, South Carolina, United States