A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants with Relapsed Small Cell Lung Cancer
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer
Xiyun Zhang
Zai Lab
Building B, 899 Halei Road, Pudong, Shanghai, 201203, China
21-61632588
xiyun.zhang@zailaboratory.com
Hara Yo
CMIC Co., Ltd.
1-1-1, Shibaura, Minato-ku, Tokyo
+81-3-6779-8000
ClinicalTrialInformation@cmic.co.jp
Recruiting
Mar. 20, 2026
May. 20, 2026
480
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
1. Age >= 18 years, or considered an adult by local regulations, at the time of consent.
2. Signed informed consent
3. Histologically or cytologically confirmed SCLC.
4. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.
5. Measurable disease according to RECIST v1.1 as assessed by the investigator.
6. Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.
7. Adequate organ and marrow function
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Life expectancy of at least 3 months.
10. Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening.
11. Participants must be willing and able to comply with the protocol for the duration of the study
1. Received more than one line of systemic therapy for Extensive-Stage SCLC.
2. Received any prior ADC with topoisomerase I inhibitor payload.
3. Participants with another known malignancy with exceptions defined in the protocol.
4. History or suspected ILD/pneumonitis based on criteria per protocol
5. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
6. Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.
7. Prior radiotherapy before study treatment based on criteria per protocol
8. Unresolved toxicity of Grade >=2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
9. Known infections or active infection defined in the protocol.
10. Clinically significant active cardiovascular disease or history of any arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.
18age old over
No limit
Both
Small Cell Lung Cancer
- Experimental: ZL-1310 as a single agent
ZL-1310 1.6 mg/kg, intravenous (IV) on Day 1, once every 3 weeks (Q3W).
- Active Comparator: Investigator's Choice of Therapy
- Topotecan 1.0 mg/m2 IV on Days 1 to 5, Q3W
- Amrubicin 40 mg/m2 IV on Days 1 to 3, Q3W
- Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Overall survival (OS)
- Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1
- Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1
- Confirmed ORR assessed by the investigator per RECIST v1.1
- Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1
- Confirmed CNS response and duration of CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM)
- Occurrence of treatment-emergent adverse events (TEAEs) including Grade >=3, serious, and fatal TEAEs. Note: TEAEs are graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
- Clinically significant changes in clinical laboratory tests
- Changes from baseline in EQ-5D-5L (EQ-5D-5L index and EQ visual analog scale (VAS))
- Changes from baseline in EORTC-QLQ-C30
- Changes from baseline in EORTC-QLQ-LC13
- Time to deterioration in patient-reported lung cancer symptoms as measured by EORTC-QLQ-C30 and EORTC-QLQ-LC13
- Time to deterioration in patient-reported HRQoL scores and physical functioning scores as measured by EORTC-QLQ-C30
Zai Lab (US) LLC
Nippon Medical School Hospital Institutional Review Board
