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New combo therapy targets tough lung cancer in early trial

NCT ID NCT07325136

Disease control Sponsor: Bristol-Myers Squibb 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 5 times

Summary

This study tests an experimental drug called BMS-986525, given alone or with the immunotherapy nivolumab (Opdivo), in 240 people whose small cell lung cancer has returned or stopped responding to standard platinum-based chemotherapy. The main goals are to check safety and tolerability, and to see if the drug shrinks tumors. The trial is currently recruiting.

What this could mean

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

Active substance
BMS-986525 (an experimental drug) and nivolumab (Opdivo, an immunotherapy)
What this could lead to
If successful, this could provide a new treatment option for people with relapsed/refractory small cell lung cancer, potentially improving tumor shrinkage or slowing disease progression.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. The experimental drug may cause side effects or fail to work better than existing treatments.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 240 people

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

Started

Feb 2026

Expected to finish

Apr 2029

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 * Participants must have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC). * Participants must have received at least 1 platinum-based chemotherapy regimen as per locally approved drug labels and institutional guidelines. * In countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with anti-PD-(L)1 therapy, it is required that participants have progressed on, are ineligible for or not have access to an anti-PD- (L)1 therapy. Exclusion Criteria * Participants must not have any untreated CNS metastases. * Participants must not have an active, known or suspected autoimmune disease. * Participants must not have had a prior organ or tissue allograft. * Other protocol-defined Inclusion/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.

Relapsed/refractory small cell lung cancer

How to take part

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

  1. The places running it

    13 sites in 6 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

  • Centrul de Oncologie Sf. Nectarie SRL

    RECRUITING

    Craiova, 200347, Romania

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Local Institution - 0018

    NOT_YET_RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • Local Institution - 0020

    NOT_YET_RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Local Institution - 0029

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100036, China

  • Oncohelp Medical Center

    RECRUITING

    Timișoara, Timiș County, 300239, Romania

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Shanghai East Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

More trials for these conditions

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