Clinical trial · Interventional
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Lurbinectedin | Drug | Lurbinectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab and lurbinectedin treatment arm
- description
- Durvalumab taken in combination with lurbinectedin in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen.
- interventionNames
- Drug: Lurbinectedin
- Drug: Durvalumab
Primary outcomes (1)
- measure
- Investigator assessed PFS rate
- timeFrame
- 6 months
- description
- 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
Secondary outcomes (5)
- measure
- Investigator assessed PFS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available