Lurbinectedin: Administered by intravenous (IV) infusion
Durvalumab: Administered by intravenous (IV) infusion
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).
2. Participant has received 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab
3. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
4. Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
5. Adequate hematologic and end-organ function for at least 7 days prior to dosing.
6. Has a body weight \> 30 kg.
7. Adequate contraceptive precautions.
Exclusion Criteria:
1. Clinically confirmed leptomeningeal carcinomatosis.
2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
3. Significant cardiovascular disease within 3 months prior to enrollment
4. History of another primary malignancy
5. Presence or history of Central Nervous System (CNS) metastases
6. History of allogeneic organ transplantation.
7. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.
8. Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment.
9. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
10. Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.
Primary outcome measure(s)
Investigator assessed PFS rate — 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
Trial sites (4)
Facility
City
Region
Status
Valkyrie Clinical Trials, Inc.
Los Angeles
California
Recruiting
Cancer Specialists of North Florida
Jacksonville
Florida
Recruiting
Emory University
Atlanta
Georgia
Recruiting
Carolina Blood and Cancer Care
Rock Hill
South Carolina
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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