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A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

StatusRecruiting
PhasePhase 2
Started2026-11-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
minor
Study Status, Study Description, Eligibility v4
Start date2026-08-30→2026-11-30
Eligibility criteria-56 characters
[...] ved 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab Has Eastern Cooperative Oncology Group Performanc [...] kg. Adequate contraceptive precautions. Exclusion Criteria: HistoryClinically ofconfirmed leptomeningeal carcinomatosis. Uncontrolled pleural effusio [...] ffusion, or ascites requiring recurrent drainage procedures Significant cardiovascular disease within 3 months prior to enrollment History of another primary malignancy Presence or history of [...] thin 30 days prior to the first dose of study intervention. Concurrent enrollment in another clinical study Prior enrol [...] [...]
Study description+29 characters
[...] D) per RECIST v1.1 criteria after completion of 4 cycles of durvalumab and platinum plus etoposide containing regimen with at least 3 cycles of durvalumab during induction treatment.
2026-07-17
notable
Study Status, Contacts/Locations v3
Recruitment opened
Trial sites expanded: 1 → 4 locations
Start date2026-06-12→2026-08-30
2026-05-22
minor
Study Status v2
Start date2026-04-25→2026-06-12
2026-04-23
minor
Study Status v1
Re-verified, no change to tracked fields
2026-03-05
minor
Original filing
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.
Trial Details
NCT Number NCT07459634
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Jazz Pharmaceuticals Ireland Limited
Conditions Extensive-stage Small-cell Lung Cancer
Enrollment 50 participants
Start Date 2026-11-30
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-17