Clinical trial · Interventional
A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-drug Conjugate (ADC) in Combination With a Checkpoint Inhibitor Compared to Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 in combination with a checkpoint inhibitor compared to standard first-line therapy in participants with Extensive-Stage Small Cell Lung Cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin | Combination Product | — | UNRESOLVED |
| Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance | Combination Product | — | UNRESOLVED |
| ZL-1310 in combination with Atezolizumab or Durvalumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ZL-1310 in Combination with Checkpoint Inhibitor
- interventionNames
- Combination Product: ZL-1310 in combination with Atezolizumab or Durvalumab
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor
- interventionNames
- Combination Product: Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin
- Combination Product: Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance
Primary outcomes (1)
- measure
- Overall survival of ZL-1310 with IO compared to chemo with IO
- timeFrame
- up to approximately 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed ES-SCLC * No prior systemic therapy has been received * Medically eligible to receive standard platinum-based chemotherapy with atezolizumab or durvalumab as first-line therapy * Eastern Cooperative Oncology Group performance status of 0 or 1 * Life expectancy of at least 3 months * Adequate organ and marrow function Exclusion Criteria: * Has a contraindication to receive atezolizumab or durvalumab according to local drug label or local treatment guideline * Participants with symptomatic CNS metastases (require initiation or dose change of steroids or anti-convulsant within 7 days prior to randomization; require steroid dose higher that prednisone 10 mg/day or equivalent within 14 days prior to randomization * History of ILD/pnuemonitis (non-infectious) that required corticosteroids, current ILD/pnuemonitis of any grade, or suspected ILD/pnuemonitis that cannot be ruled out by imaging at screening * Received radiotherapy within 2 weeks to the non-thoracic and within 4 weeks to the thoracic area prior to the first dose of study treatment or received more than 30 Gy of thoracic radiotherapy * Clinically significant active cardiovascular disease or history of any arterial thromboembolic event within 6 months prior to the first dose of study treatment * Clinically severe pulmonary compromise (including but not limited to baseline oxygen saturation of \<90% on room air) resulting from intercurrent pulmonary illnesses * Major surgery within 4 weeks prior to the first dose of study treatment.
References
Publications (0)
Data not yet available