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New hope for tough lung cancer: tarlatamab trial targets advanced disease

NCT ID NCT06502977

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tests a drug called tarlatamab in 32 Chinese adults with advanced small cell lung cancer that has worsened after at least two prior treatments. The main goal is to see if the drug can shrink tumors. Researchers will also monitor side effects and how long any response lasts.

What this could mean

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

Active substance
tarlatamab (a drug given by IV infusion)
What this could lead to
If successful, this could provide a new treatment option for Chinese patients with advanced small cell lung cancer who have run out of standard therapies.
What could go wrong
This is an early Phase 2 study with only 32 participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors in many patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

32 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Sep 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: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Participant must be a resident in China, and of Chinese ancestry ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent. * Histologically or cytologically confirmed small cell lung cancer. * Extensive-stage SCLC participants who progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a PD-1/PD-\[L\]1) and at least 1 other prior line of therapy. * Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of study drug. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Minimum life expectancy of 12 weeks. * Adequate organ function. Exclusion Criteria: Disease Related * Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC. * Symptomatic central nervous system (CNS) metastases. * Diagnosis or evidence of leptomeningeal disease. * Prior history of severe or life-threatening events from any immune-mediated therapy. Other Medical Conditions * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. * History of solid organ transplantation. * Evidence of interstitial lung disease or active, non-infectious pneumonitis. * History of other malignancy within the past 2 years, with certain exceptions * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of study drug. * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of study drug. * Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study drug. * HIV, Hepatitis B, and Hepatitis C, with certain exceptions. * Major surgery within 28 days of first dose study drug. Prior/Concomitant Therapy * Currently or previously enrolled in a tarlatamab study. * Prior therapy with any selective inhibitor of the DLL3 pathway. * Prior anti-cancer therapy within 21 days prior to first dose of study treatment, with certain exceptions. * Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug, with certain exceptions. * Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study drug. Inactive vaccines (eg, non-live or non-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for mpox infection) within 3 days prior to first dose of study drug. Prior/Concurrent Clinical Study Experience • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. Other Exclusions * Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol. * Female participants who are breastfeeding or who plan to breastfeed while on study and for an additional period of time after the last dose of study drug as specified in the study protocol. * Female participants planning to become pregnant or donate eggs while on study and for an additional period of time after the last dose of study drug as specified in the study protocol. * Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test. * Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol. * Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol. * Male participants unwilling to abstain from donating sperm during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol. * Participants has known sensitivity to any of the products or components to be administered during dosing. * Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures. * History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Army Special Medical Center of Peoples Liberation Army

    Chongqing, Chongqing Municipality, 400042, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Fujian Cancer Hospital

    Fuzhou, 350011, China

  • Harbin Meidical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000, China

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang, 317000, China

  • The Second Affiliated Hospital of Army Medical University, People's Liberation Army

    Chongqing, Chongqing Municipality, 400037, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

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