A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lurbinectedin
- Durvalumab
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Ireland Limited
Collaborator
Source ClinicalTrials.gov