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Recruiting
NCT07459634
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Conditions: Extensive-stage Small-cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: Jazz Pharmaceuticals
Location: Valkyrie Clinical Trials, Inc. Los Angeles California
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07459634). StuddyBuddy aggregates publicly available trial information.