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New combo therapy shows promise for tough lung cancer

NCT ID NCT04885998

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a combination of two drugs, tarlatamab and AMG 404, in 23 adults with small cell lung cancer that had worsened after standard chemotherapy. The main goal was to check safety and find the right dose for future studies. Participants had to be in fairly good health (ECOG 0-1) and could have treated brain metastases.

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

23 people

The number who actually took part.

Started

Sep 2021

Finished

Sep 2024

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/assent prior to initiation of any study specific activities/procedures * Age greater than or equal to 18 years old at the same time of signing the informed consent * Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen * Eastern Cooperative Oncology Group (ECOG) 0 to 1 * Participants with treated brain metastases are eligible provided they meet defined criteria * Adequate organ function as defined in protocol Exclusion Criteria: * History of other malignancy within the past 2 years with exceptions * Major surgery within 28 days of first dose of tarlatamab * Untreated or symptomatic brain metastases and leptomeningeal disease * Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab Exceptions: * Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1. * Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab * Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible * Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents * History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis * Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab * History of solid organ transplantation * History of hypophysitis or pituitary dysfunction * 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. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted

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Conditions

The condition(s) this trial relates to.

lung neoplasm small cell lung carcinoma

As listed by the trial registrant

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

Small cell lung cancer

Contacts and locations

Locations

  • Chung Shan Medical University Hospital

    Taichung, 40201, Taiwan

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020, Austria

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cancer Centre Singapore

    Singapore, 169610, Singapore

  • National University Hospital

    Singapore, 119074, Singapore

  • Northwestern University, Robert H Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090, Austria

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • Wake Forest Baptist Comprehensive Cancer Research Center

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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