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New Antibody-Like drug joins forces with standard chemo to fight lung cancer

NCT ID NCT06077500

Disease control Sponsor: Boehringer Ingelheim 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 6 times

Summary

This early-phase trial tests a new drug called BI 764532 (obrixtamig) added to standard chemotherapy and immunotherapy for people with extensive-stage small cell lung cancer. The main goal is to find the highest safe dose of BI 764532 when given with standard treatments. About 46 adults will receive the combination as intravenous infusions, and researchers will monitor side effects and tumor response.

What this could mean

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

Active substance
BI 764532 (obrixtamig) plus carboplatin, etoposide, and atezolizumab
What this could lead to
If it works, this could point toward a more effective first-line treatment for extensive-stage small cell lung cancer.
What could go wrong
This is an early Phase 1 trial with only 46 participants, focused on safety and dosing. The combination may cause significant side effects and may not improve outcomes.

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

46 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Apr 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: * Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) * Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Histologically or cytologically confirmed extensive-stage small cell lung carcinoma (ES-SCLC) * Availability of archival tumour tissue * Patients must be eligible for platinum+etoposide+anti-Programmed Cell Death Ligand 1 (PD-L1) regimen as first line standard of care (SoC) treatment: * In Part A, patients must be eligible to receive carboplatin + etoposide + atezolizumab * In Part B, patients must be eligible to receive etoposide, carboplatin or cisplatin, and atezolizumab or durvalumab * No prior systemic treatment for ES-SCLC * Prior systematic anti-cancer treatment for limited-stage small cell lung cancer (SCLC) must have been complete at least 6 months prior to the diagnosis of ES-SCLC * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply. Exclusion Criteria: * Previous treatment in this trial * Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is longer) of the first administration of trial medication * Presence of leptomeningeal carcinomatosis * Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers and cell therapies * Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532 * Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy) * Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement * Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.

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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.

Small cell lung carcinoma (SCLC)

Contacts and locations

Locations

  • AZ Groeninge

    Kortrijk, 8500, Belgium

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • HOP Civil

    Strasbourg, 67091, France

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192, Japan

  • Hopital Louis Pradel

    Bron, 69677, France

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009, Spain

  • INS Bergonie

    Bordeaux, 33000, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto Valenciano de Oncología

    Valencia, 46009, Spain

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550, Japan

  • Med Polonia Sp. z o.o

    Poznan, 60-693, Poland

  • Medical University Gdansk

    Gdansk, 80-214, Poland

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, 93-338, Poland

  • Saitama Medical University International Medical Center

    Saitama, Hidaka, 350-1298, Japan

  • University Hospital of Lausanne

    Lausanne, 1011, Switzerland

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392, Germany

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