CompletedPhase 2

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

United States, Australia, Belgium135 participantsStarted 2021-03-17

Plain-language summary

The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV \[T any, N any, M1a, M1b, or M1c\], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan) * Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic) * Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 * At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria * Adequate hematologic and end organ function * Must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended * Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded * Symptomatic brain or other central nervous system (CNS) metastases * Pa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combined an experimental antibody called BMS-986012 with carboplatin, etoposide, and nivolumab — how does adding BMS-986012 to that existing regimen compare to just the standard carboplatin, etoposide, and nivolumab combination that's already approved for my stage of small cell lung cancer?
2Since this is a Phase 2 trial that has already completed, what do the results actually show about safety — specifically how many participants experienced serious adverse events or had to stop treatment early — and what would that mean for someone in my situation?
3The trial tracked how long patients went without their cancer getting worse, called progression-free survival — based on what you know of the results, does the data suggest any meaningful difference compared to what I'd expect from standard first-line therapy?
4Because this trial is now completed and I can no longer enroll in it, are there any follow-on studies, expanded access programs, or other trials involving BMS-986012 or similar approaches that might be worth considering for my case?
5Given that extensive-stage small cell lung cancer can progress quickly, how would you weigh starting with the current standard of care right now versus waiting to see if a trial testing this kind of combination becomes available to me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events

Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

Number of Participants With Serious Adverse Events

Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

Number of Participants With Adverse Events Leading to Discontinuation

Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

Number of Participants Who Died

Timeframe: From first dose to primary cutoff date (Up to approximately 43 months)

Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)

Timeframe: From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months)

Trial details

NCT IDNCT04702880

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-22

Results submitted2026-05-20

View on ClinicalTrials.gov More Extensive-stage Small Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Adverse Events

Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

Number of Participants With Serious Adverse Events

Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

Number of Participants With Adverse Events Leading to Discontinuation

Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

Number of Participants Who Died

Timeframe: From first dose to primary cutoff date (Up to approximately 43 months)

Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)

Timeframe: From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months)