Extensive-Stage Small Cell Lung CancerPhase 3NCT07796100
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 Phase 3 study testing ZL-1310 in combination with Atezolizumab or Durvalumab, Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin and Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance in people with Extensive-Stage Small Cell Lung Cancer, run by Zai Lab (Shanghai) Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- ZL-1310 in combination with Atezolizumab or Durvalumab, Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin and Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 30 Jun 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- ZL-1310 in combination with Atezolizumab or Durvalumab, Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin, Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-1310 in combination with Atezolizumab or DurvalumabCombination product
ZL-1310 ADC in combination with checkpoint inhibitor
Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with LurbinectedinCombination product
Platinum-based chemotherapy in combination with a checkpoint inhibitor
Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenanceCombination product
Standard of Care Platinum-based chemotherapy in combination
| Study group | Role | What they receive |
|---|---|---|
| ZL-1310 in Combination with Checkpoint Inhibitor | Experimental | Not described Receives: Combination Product: ZL-1310 in combination with Atezolizumab or Durvalumab |
| Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor | Active comparator | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of ZL-1310 with IO compared to chemo with IO
Measured: up to approximately 3 years
Secondary outcomes (12)
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Measured: up to approximately 3 years
Confirmed objective response rate (ORR) assessed by BICR and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Measured: up to approximately 3 years
Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310with IO compared to chemo with IO
Measured: up to approximately 3 years
Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Measured: up to approximately 3 years
Confirmed central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO
Measured: up to approximately 3 years
Duration of central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO
Measured: up to approximately 3 years
Incidence rate of new brain metastases in participants without baseline brain metastases of ZL-1310 with IO compared to chemo with IO
Measured: up to approximately 3 years
Time to first onset of new brain metastases in participants without baseline brain metastases of ZL-130
Measured: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ-5D-5L index)
Measured: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ visual analog scale [VAS]).
Measured: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-LC13
Measured: up to approximately 3 years
Changes from baseline in quality of life parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-C30
Measured: up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start31 Dec 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (US) LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796100
- Sponsor's protocol ID
- ZL-1310-005
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07796100
- Acronym / sponsor ID
- ZL-1310-005
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (US) LLC
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZL-1310 in Combination with Checkpoint Inhibitor | Experimental | Combination Product: ZL-1310 in combination with Atezolizumab or Durvalumab |
| Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor | Active comparator | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZL-1310 in combination with Atezolizumab or DurvalumabZL-1310 ADC in combination with checkpoint inhibitor | Combination product | ZL-1310 in Combination with Checkpoint Inhibitor |
| Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with LurbinectedinPlatinum-based chemotherapy in combination with a checkpoint inhibitor | Combination product | Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor |
| Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenanceStandard of Care Platinum-based chemotherapy in combination | Combination product | Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor |
Primary outcome
Overall survival of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
12 secondary outcomes
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Confirmed objective response rate (ORR) assessed by BICR and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310with IO compared to chemo with IO
Time frame: up to approximately 3 years
Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Confirmed central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Duration of central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Incidence rate of new brain metastases in participants without baseline brain metastases of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Time to first onset of new brain metastases in participants without baseline brain metastases of ZL-130
Time frame: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ-5D-5L index)
Time frame: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ visual analog scale [VAS]).
Time frame: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-LC13
Time frame: up to approximately 3 years
Changes from baseline in quality of life parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-C30
Time frame: up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZL-1310 in combination with Atezolizumab or Durvalumab, Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin and Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance in people with Extensive-Stage Small Cell Lung Cancer, run by Zai Lab (Shanghai) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZL-1310-005 Study Team (650-360-1601, Study-ZL-1310-005@zailaboratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of ZL-1310 with IO compared to chemo with IO (time frame: up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.