NCT07796100Not yet recruitingPhase 3
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 · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 530 (estimated)
- First submitted
- 24 Aug 2026
- Start date
- 31 Dec 2026
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07796100
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 530
- From 31 Dec 2026 to the primary completion date, 30 Jun 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- Major surgery within 4 weeks prior to the first dose of study treatment.
Other illness
- 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
- Clinically severe pulmonary compromise (including but not limited to baseline oxygen saturation of \<90% on room air) resulting from intercurrent pulmonary illnesses
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.