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Phase 2Recruiting

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

Sponsored by Jazz Pharmaceuticals

About this study

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.

The study will evaluate the safety and efficacy of lurbinectedin in combination with durvalumab as maintenance therapy in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. In order to be considered for eligibility screening for the maintenance phase, participants need to have an ongoing CR, PR, or stable disease (SD) per RECIST v1.1 criteria after completion of 4 cycles of platinum plus etoposide containing regimen with at least 3 cycles of durvalumab during induction treatment.

Where this study is enrolling

Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.