Relapsed/Refractory Small Cell Lung CancerPhase 1/2NCT07325136
A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer
A Phase 1/2 study testing BMS-986525 and Pumitamig in people with Relapsed/Refractory Small Cell Lung Cancer, run by Bristol-Myers Squibb at 13 sites in 6 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Pumitamig in participants with Relapsed/Refractory Small Cell Lung Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Small Cell Lung Cancer
- What is being tested?
- BMS-986525 and Pumitamig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 3 Feb 2026to 24 Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
13 sites in 6 countries
United States5 sites, 5 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Prantesh Jain, Site 0026, 716-845-3099
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Afshin Dowlati, Site 0004, 216-844-5432
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Hirva Mamdani, Site 0011, 313-576-8711
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Neal Ready, Site 0005, 919-681-7460
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Melissa Johnson, Site 0006, 615-329-7274
China2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0029
Beijing, Beijing Municipality, 100036
Site 0029
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Caicun Zhou, Site 0028, 8613301825532
Japan2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0018
Chuo-ku, Tokyo, 104-0045
Site 0018
- Not yet recruiting
Local Institution - 0020
Hirakata, Osaka, 573-1191
Site 0020
Romania2 sites, 2 recruiting
- Recruiting
Centrul de Oncologie Sf. Nectarie SRL
Craiova, 200347
Michael Schenker, Site 0003, 40727774974
- Recruiting
Oncohelp Medical Center
Timișoara, Timiș County, 300239
Cristina Oprean, Site 0023, +40745148485
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Matteo Simonelli, Site 0001, +390282244559
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Luis Paz-Ares Rodriguez, Site 0009, 0034913908922
About this study
Official title: A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer
The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Pumitamig in participants with Relapsed/Refractory Small Cell Lung Cancer
- Being tested
- BMS-986525, Pumitamig
- Keywords
- Extensive stage-small cell lung cancer (ES-SCLC)
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986525Drug
Specified dose on specified days
PumitamigDrug
Also called BNT-327, BMS-986545
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: BMS-986525 Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: BMS-986525 |
| Part 2A: BMS-986525 Monotherapy Dose Expansion | Experimental | Not described Receives: Drug: BMS-986525 |
| Part 1B: BMS-986525 Combination with Pumitamig Dose Escalation | Experimental | Not described Receives: Drug: BMS-986525; Drug: Pumitamig |
| Part 2B: BMS-986525 Combination with Pumitamig Dose Expansion | Experimental | Not described Receives: Drug: BMS-986525; Drug: Pumitamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately 2 years
Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria
Measured: Up to 21 days
Number of participants with AEs leading to discontinuation
Measured: Up to approximately 2 years
Number of participants with AEs leading to death
Measured: Up to approximately 2 years
Secondary outcomes (4)
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment
Measured: Up to approximately 3 years
Maximum observed concentration within a dosing interval (Cmax)
Measured: Up to approximately 2 years
Time of maximum observed plasma concentration within a dosing interval (Tmax)
Measured: Up to approximately 2 years
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start3 Feb 2026
- Primary completion23 Apr 2029 (estimated)
- Study completion24 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325136
- Sponsor's protocol ID
- CA258-0001
- Other IDs
- 2025-524090-16, 2025
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07325136
- Acronym / sponsor ID
- CA258-0001
- Keywords
- Extensive stage-small cell lung cancer (ES-SCLC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 23 Apr 2029 (estimated)
- Study completion
- 24 Apr 2029 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Pumitamig in participants with Relapsed/Refractory Small Cell Lung Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1A: BMS-986525 Monotherapy Dose Escalation | Experimental | Drug: BMS-986525 |
| Part 2A: BMS-986525 Monotherapy Dose Expansion | Experimental | Drug: BMS-986525 |
| Part 1B: BMS-986525 Combination with Pumitamig Dose Escalation | Experimental | Drug: BMS-986525, Drug: Pumitamig |
| Part 2B: BMS-986525 Combination with Pumitamig Dose Expansion | Experimental | Drug: BMS-986525, Drug: Pumitamig |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986525Specified dose on specified days | Drug | Part 1A: BMS-986525 Monotherapy Dose Escalation, Part 1B: BMS-986525 Combination with Pumitamig Dose Escalation, Part 2A: BMS-986525 Monotherapy Dose Expansion, Part 2B: BMS-986525 Combination with Pumitamig Dose Expansion |
| PumitamigAlso: BNT-327, BMS-986545Specified dose on specified days | Drug | Part 1B: BMS-986525 Combination with Pumitamig Dose Escalation, Part 2B: BMS-986525 Combination with Pumitamig Dose Expansion |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria
Time frame: Up to 21 days
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 2 years
Number of participants with AEs leading to death
Time frame: Up to approximately 2 years
4 secondary outcomes
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment
Time frame: Up to approximately 3 years
Maximum observed concentration within a dosing interval (Cmax)
Time frame: Up to approximately 2 years
Time of maximum observed plasma concentration within a dosing interval (Tmax)
Time frame: Up to approximately 2 years
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986525 and Pumitamig in people with Relapsed/Refractory Small Cell Lung Cancer, run by Bristol-Myers Squibb at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, China, Japan, Romania, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to approximately 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.