Tests ZL-1310 against standard treatment in relapsed small cell lung cancer
Compares ZL-1310 with standard treatment in adults with returned small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
Key facts
- Where
- Beijing, Changchun, Changsha, Chengdu, Fuzhou, Guangzhou, Hangzhou, Hefei, Heilongjiang, Jinan, Linyi, Nanchang, Naning, Nanjing, Shanghai, Shijiazhuang, Taizhou, Wuhan, Xi’an, Xiamen, and Zhengzhou, ChinaSee the 23 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose small cell lung cancer came back or got worse after first treatment with platinum-based chemotherapy.
- Age
- 18 years or older (or an adult under local rules)
- Sex
- All sexes can join.
- Disease stage
- Small cell lung cancer confirmed by tissue or cell tests, with measurable disease. Brain spread is allowed if treated and stable, or untreated and without symptoms.
- Earlier treatment
- Must have had first-line platinum-based treatment, with the disease getting worse during or after the latest treatment. Second-line tarlatamab is allowed. Cannot have had more than one line of treatment for extensive-stage disease.
Main reasons for not taking part
- Another known cancer, with some exceptions set in the protocol
- History or suspicion of interstitial lung disease or pneumonitis
- Earlier treatment with an antibody-drug conjugate carrying a topoisomerase 1 inhibitor
- Anti-cancer treatment within 3 weeks before the first dose
- Active infection or clinically significant active heart or blood vessel disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has your cancer come back or got worse during or after treatment with platinum chemotherapy?
- Has your cancer spread to the brain?
Source: NCT07218146, who can take part
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
- Jilin Cancer HospitalChangchun, ChinaTaking people
- Hunan Cancer HospitalChangsha, ChinaTaking people
- Sichuan Cancer HospitalChengdu, ChinaTaking people
- Fujian Cancer HospitalFuzhou, ChinaTaking people
- Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaTaking people
- Anhui Provincial HospitalHefei, ChinaTaking people
- Harbin medical university cancer hospitalHeilongjiang, ChinaTaking people
- Shandong Cancer HospitalJinan, ChinaTaking people
- LinYi Cancer HospitalLinyi, ChinaTaking people
- Jiangxi Cancer HospitalNanchang, ChinaTaking people
- Guangxi Medical University Affiliated Tumor HospitalNaning, ChinaTaking people
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
- Shanghai Pulmonary HospitalShanghai, ChinaTaking people
- Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaTaking people
- Hubei Cancer HospitalWuhan, ChinaTaking people
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaTaking people
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zai Lab (Shanghai) Co., Ltd.
- Trial code
- NCT07218146
- Record updated
- 16 October 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.Read full original descriptionShow less
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
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.
Inclusion: Age >/= 18 years, or considered an adult by local regulations, at the time of consent; Signed informed consent; Histologically or cytologically confirmed SCLC. 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; Measurable disease according to RECIST v1.1 as assessed by the investigator; Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol; Adequate organ and marrow function; Eastern Cooperative Group (ECOG) performance status of 0 or 1; Life expectancy of at least 3 months; Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening; Participants must be willing and able to comply with protocol for the duration of the study.
Exclusion: Received more than one line of systemic therapy for Extensive-Stage SCLC; Received any prior ADC with topoisomerase 1 inhibitor payload; Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment; Prior radiotherapy before study treatment based on criteria per protocol; Unresolved toxicity of Grade >/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation; Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol; Participants with another known malignancy with exceptions defined in the protocol; History or suspected ILD/pneumonitis based on criteria per protocol; Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses; Known infection or active infection defined in the protocol.