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New drug cocktail targets tough lung cancer

NCT ID NCT06179069

Disease control Sponsor: Zai Lab (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests a new drug called ZL-1310, alone or with standard treatments (atezolizumab and carboplatin), in people with small cell lung cancer. About 339 participants will join to see if the combination is safe and shrinks tumors. The goal is to find better ways to control this aggressive cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZL-1310 (a drug) combined with atezolizumab and carboplatin
What this could lead to
If successful, this could point toward a new treatment option for small cell lung cancer, potentially improving tumor control and survival.
What could go wrong
This is an early Phase 1 trial, so safety and effectiveness are not yet proven. Side effects may occur, and the drug may not work for all participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 339 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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: 1. Subjects with untreated and asymptomatic brain metastases. 2. 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. * 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.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCLC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250000, China

  • Barbara Ann Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • City of Hope

    WITHDRAWN

    Duarte, California, 91010, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510030, China

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Harbin Medical University Cancer Hospital

    WITHDRAWN

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Hospital Regional Universitario de Malaga - Hospital General H

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hunan Cancer Hospital

    WITHDRAWN

    Changsha, Hunan, 410013, China

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

    RECRUITING

    Barcelona, Barcelona, 8035, Spain

  • Jilin Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Ch’ang-ch’un, Jilin, 130012, China

  • Liaoning Cancer Hospital & Institute

    WITHDRAWN

    Shenyang, Liaoning, 110041, China

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NEXT Oncology - Hospital Quironsalud Madrid

    RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

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

    TERMINATED

    Nanjing, Jiangsu, 210008, China

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • START Barcelona_HM Nou Delfos

    RECRUITING

    Barcelona, 08023, Spain

  • START MADRID_Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Sarah Cannon Research Institute

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, Sichaun, 610041, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    WITHDRAWN

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Xiamen University

    WITHDRAWN

    Xiamen, Fujian, 361000, China

  • The Second Affiliated Hospital of Nanchang University

    TERMINATED

    Nanchang, Jiangxi, 330006, China

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

    RECRUITING

    Wuhan, Hubei, 430022, China

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Pittsburgh Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.