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SCLCPhase 1NCT06179069

A Study of ZL-1310 in Subjects With Small Cell Lung Cancer

A Phase 1 study testing ZL-1310, Atezolizumab and Carboplatin in people with SCLC, run by Zai Lab (Shanghai) Co., Ltd. at 41 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SCLC
What is being tested?
ZL-1310, Atezolizumab and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
339 participants
Where
41 sitesin 4 countries
Study dates
23 Jan 2024to 31 Jul 2027
Phase
Phase 1
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

  • Signed informed consent
  • Participant with metastatic or extensive-stage small cell lung cancer (de novo, not transformed) and for Part 1A and 1B must have documented disease progression during or following a platinum-based chemotherapy regimen. For Part 1C and Part 4, no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC). For Part 1B backfill and Part 3, first-line setting: no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC); or, first-line maintenance setting: participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin, etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. For Part 2-1, participants must have received no more than 2 lines of prior therapies in the extensive-stage setting, and progressed on or after a platinum-based chemotherapy regimen AND an anti-DLL3 T-cell engager (TCE). For Part 3, participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator.
  • Adult men and women ≥18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subjects must have at least one measurable target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI.
  • Subjects must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample at screening per protocol guidelines.
  • Life Expectancy >/= 3 months.

Who cannot join

  • Participants with another known malignancy that is progressing or requires active treatment within the last 2 years. Exceptions: basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin with previously administered curative treatment, in situ cervical cancer, or other cancers that do not require systemic anti-cancer therapies and will not impact life expectancy.
  • Symptomatic or untreated brain metastasis requiring concurrent treatment. For Part 2, Part 3, and Part 4 the following subjects can be enrolled if they have a stable neurologic status for at least 2 weeks prior to the first dose of ZL-1310:
  • Subjects with untreated and asymptomatic brain metastases.
  • Subjects with treated brain metastases that are no longer symptomatic (i.e. without neurologic signs or symptoms), who require no treatment with steriods or anticonvulsants and have recovered from the actue toxic effects of radiotherapy.
  • Subjects with leptomeningeal disease.
  • Treatment with any systemic anti-cancer treatment or other investigational products/ device within 3 weeks before first dose of study treatment.
Show all 18Show fewer
  • Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or have had a history of radiation pneumonitis.
  • Major surgery within 4 weeks of the first dose of study treatment.
  • Hypersensitivity to any ingredient of the study treatment.
  • Inadequate organ function (as defined in protocol) within 10 days prior to the first dose of study treatment,
  • Participants with a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer.
  • Participants have received a live or live-attenuated vaccine within 30 days of planned start of study therapy.
  • Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
  • Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders, including but not limited to pneumonitis.
  • Pregnant or nursing (lactating) women.
  • Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first study treatment, whichever is longer.
  • For Part 1C and Part 4 (ZL-1310 in combination with Atezolizumab and Carboplatin), participants who received prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
  • For Part 1B (ZL-1310 in combination with Atezolizumab) and Part 1C (ZL-1310 in combination with Atezolizumab and Carboplatin), participants who received systemic immunostimulatory agents (including but not limited to, IFNs and IL2) within 4 weeks or 5 drug-elimination half-lives, whichever is longer, prior to the initiation of study treatment.

Trial locations and contacts

41 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Erin Nurre contact

6503601601

Study-ZL-1310-001@zailaboratory.com

Mona Qureshi contact

6503601601

Study-ZL-1310-001@zailaboratory.com

41 sites in 4 countries

China16 sites, 8 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Jilin Cancer Hospital

    Ch’ang-ch’un, Jilin, 130012

    Active, not recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Withdrawn

  • Sichuan Cancer Hospital

    Chengdu, Sichaun, 610041

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510030

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Withdrawn

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Recruiting

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250000

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Terminated

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Terminated

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110041

    Withdrawn

  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430022

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Withdrawn

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361000

    Withdrawn

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Recruiting

Other trials in China

United States11 sites, 10 recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Withdrawn

  • Duke University

    Durham, North Carolina, 27710

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06519

    Recruiting

  • University of Pittsburgh Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Sarah Cannon Research Institute

    Sarasota, Florida, 34232

    Recruiting

Other trials in United States

Spain11 sites, 11 recruiting

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    Barcelona, Barcelona, 8035

    Site: 8002

    Recruiting

  • START Barcelona_HM Nou Delfos

    Barcelona, 08023

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    Recruiting

  • START MADRID_Hospital Universitario HM Sanchinarro

    Madrid, 28050

    Recruiting

  • Hospital Regional Universitario de Malaga - Hospital General H

    Málaga, 29010

    Recruiting

  • NEXT Oncology - Hospital Quironsalud Madrid

    Pozuelo de Alarcón, 28223

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41009

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

    Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, Valencia, 46026

    Recruiting

Other trials in Spain

Israel3 sites, 3 recruiting

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492

    Recruiting

  • The Chaim Sheba Medical Center

    Ramat Gan, Central District, 5262100

    Recruiting

  • Tel Aviv Sourasky Medical Center Ichilov

    Tel Aviv, Tel Aviv, 6423906

    Recruiting

Other trials in Israel

About this study

Official title: An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Participants With Small Cell Lung Cancer

An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer

Read the detailed description

This is an open-label, ascending, multiple-dose, phase 1 study evaluating ZL-1310 as a single agent, in combination with Atezolizumab, and in combination with Atezolizumab and Carboplatin in subjects with extensive SCLC.

Conditions
SCLC
Being tested
ZL-1310, Atezolizumab, Carboplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06179069
Study groupRoleWhat they receive
Dose Escalation: Part 1AExperimentalZL-1310 as a single-agent
Receives: Drug: ZL-1310
Dose Expansion: Part 1BExperimentalZL-1310 in combination with Atezolizumab
Receives: Drug: ZL-1310; Drug: Atezolizumab
Dose Escalation: Part 1CExperimentalZL-1310 in combination with Atezolizumab and Carboplatin as induction and followed by ZL-1310 and Atezolizumab as maintenance
Receives: Drug: ZL-1310; Drug: Atezolizumab; Drug: Carboplatin
Dose Expansion: Arm 1 (Part 2)ExperimentalDose level 1 of ZL-1310 established from single-agent dose-escalation
Receives: Drug: ZL-1310
Dose Expansion: Arm 2 (Part 2)ExperimentalDose level 2 of ZL-1310 established from single-agent dose escalation
Receives: Drug: ZL-1310
Dose Extension: Arm 1 (Part 2)ExperimentalZL-1310 as a single agent
Receives: Drug: ZL-1310
Doublet Dose Optimization: Arm 1 (Part 3A)ExperimentalDose level 1 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab
Receives: Drug: ZL-1310; Drug: Atezolizumab
Doublet Dose Optimization: Arm 2 (Part 3A)ExperimentalDose level 2 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab
Receives: Drug: ZL-1310; Drug: Atezolizumab
Triplet Dose Optimization: Arm 1 (Part 4A)ExperimentalDose level 1 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + Atezolizumab as maintenance
Receives: Drug: ZL-1310; Drug: Atezolizumab; Drug: Carboplatin
Triplet Dose Optimization: Arm 2 (Part 4A)ExperimentalDose level 2 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + atezolizumab as induction
Receives: Drug: ZL-1310; Drug: Atezolizumab; Drug: Carboplatin
Dose Extension: Part 2-1Experimentalsingle-agent dose extension for Post-anti-DLL3
Receives: Drug: ZL-1310
Doublet Dose Extension: Part 3BExperimentalDoublet dose extension for 1L maintenance only OR 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data.
Receives: Drug: ZL-1310; Drug: Atezolizumab
Triplet Dose Extension: Part 4BExperimentalTriplet dose extension for 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data.
Receives: Drug: ZL-1310; Drug: Atezolizumab; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities of ZL-1310 as a single agent (Part 1A), in combination with Atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)

    Number of subjects with Dose Limiting Toxicities (DLTs)

    Measured: up to 24 months

  2. Incidence of Treatment Emergent Adverse-Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)

    Number of subjects with treatment-emergent adverse events (TEAEs)

    Measured: up to 24 months

  3. Incidence of Serious Adverse Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)

    Number of subjects with serious adverse events

    Measured: up to 24 months

  4. Incidence of Treatment Emergent Adverse Events of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3) and in combination with atezolizumab and carboplatin (Part 4)

    Number of subjects with treatment emergent adverse events leading to dose modifications and/or study treatment discontinuation

    Measured: up to 24 months

  5. Incidence of Serious Adverse-Events (SAEs) of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4)

    Number of subjects with serious adverse events

    Measured: up to 24 months

  6. Antitumor activity per RECIST v1.1 by investigator's assessment of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4)

    antitumor activity per RECIST v1.1 by investigator's assessment

    Measured: up to 24 months

  7. Objective response rate (ORR) per RECIST v1.1 of ZL-1310 as a single agent (Part 2) and in combination with atezolizumab and carboplatin (Part 4)

    objective response rate per RECIST v1.1

    Measured: up to 24 months

  8. Disease control rate (DCR) per RECIST v1.1 of ZL-1310 in combination with atezolizumab

    disease control rate per RECIST v1.1

    Measured: up to 24 months

Secondary outcomes (7)

  1. Objective response rate (ORR) per RECIST 1.1 of ZL-1310 as a single agent (Part 1A) in combination with atezolizumab (Part 1B), in combination with atezolizumab and carboplatin (Part 1C, Part 3)

    Objective Response Rate (ORR) per RECIST 1.1

    Measured: up to 24 months

  2. Disease control rate (DCR) per RECIST v1.1 of ZL-1310 as a single agent (Part 1A and Part 2), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 4)

    Disease control rate (DCR) per RECIST v1.1

    Measured: up to 24 months

  3. Duration of response per RECIST v1.1

    Duration of response per RECIST v1.1

    Measured: up to 24 months

  4. Progression free survival per RECIST v1.1

    Progression free survival per RECIST v1.1

    Measured: up to 24 months

  5. Overall Survival of ZL-1310

    Overall Survival of ZL-1310

    Measured: up to 24 months

  6. Pharmacokinetics: Total Antibody of ZL-1310

    Pharmacokinetics: Total Antibody of ZL-1310

    Measured: up to 24 months

  7. Pharmacokinetics: Unconjugated payloads of ZL-1310

    Pharmacokinetics: Unconjugated payloads of ZL-1310

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2023
  2. Study start23 Jan 2024
  3. Primary completion30 May 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
339 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06179069
Sponsor's protocol ID
ZL-1310-001
Status last verified
Mar 2026
First submitted
7 Dec 2023
Last updated
16 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZL-1310, Atezolizumab and Carboplatin in people with SCLC, run by Zai Lab (Shanghai) Co., Ltd. at 41 sites in 4 countries.

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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in China, United States, Spain, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Erin Nurre (6503601601, Study-ZL-1310-001@zailaboratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities of ZL-1310 as a single agent (Part 1A), in combination with Atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) (time frame: up to 24 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06179069.

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 16 Oct 2026.

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